MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-14 for ANGLED TI TOP LOADING TRANSCONNECTOR/MEDIUM 04.614.551 manufactured by Wrights Lane Synthes Usa Products Llc.
[188839626]
(b)(4). A product investigation was conducted. Visual inspection: the angled ti top loading transconnector medium (p/n: 04. 614. 551, lot #: 7348874) was returned and received at us cq. Upon visual inspection, it was observed that the device was received assembled with two ti trans connector locking screws (p/n: 04. 614. 522, lot #: unk) and one ti trans connector locking nut 7. 5 mm. There were no defects identified with the returned device. Functional test: the functional test was performed on the returned device. The attempt to disassemble the ti trans connector locking screw from the angled ti top loading trans connector/medium and ti trans connector locking nut 7. 5 mm failed as the devices were stuck. The mating devices were investigated under a different pi in the same pc. The male link was observed to be sliding through the female link tight when the locking sleeve was in the locked position. The complaint can be replicated with the returned device. Dimensional analysis: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device. Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed yes, the device received will not lock. Hence confirming the allegation. Investigation conclusion: the complaint condition is confirmed for the angled ti top loading transconnector medium (p/n: 04. 614. 551, lot #: 7348874). There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. A device history record (dhr) review was conducted: part number: 04. 614. 551, lot number: 7348874, part manufacturer date: 03 apr 2013, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of angled ti top loading transconnector / medium was processed through the normal manufacturing and inspection operations with no non-conformance's or rework noted. The lot quantity of 24 pieces met all-dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Assembly components device history (lot) review: part number: 04. 614. 551. 20. Lot number: 7244440. Part manufacturer date: 08 feb 2013. Manufacturing location: elmira. Part expiration date: n/a. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of link, female? Angled adjustable transconnector was processed through the normal manufacturing and inspection operations. Non-conformance ncr was written as 1 piece of 35 was scrapped due to oversize slot length feature l6. This non-conformance had no impact on the complaint condition. No other non-conformance's or rework were noted. The final lot quantity of 35 pieces met all-dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Dhr records review: a review of the device history records of the components revealed no complaint related anomalies. The lots being processed through the normal manufacturing and inspection operations with no non-conformance's or rework noted. The lot quantities met all-dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition. Dhr record review: a review of the device history record revealed no complaint related anomalies. The device history record shows this lot of angled ti top loading transconnector / medium was processed through the normal manufacturing and inspection opera. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188839627]
It was reported that on (b)(6) 2020, the surgeon was performing c2-6 posterior cervical fusion procedure using the 4. 0 synapse system. Near the end of the case, after the surgeon applied two transconnector locking set screws and eight (8) titanium locking screws to the remaining screws, the doctor then finally tightened all ten (10) set screws. The physician attempted to seat a medium synapse top loading transconnector to the transconnector set screws. He then applied a 7. 5mm transconnector locking nut to the left side of the transconnector but when he attempted to apply and seat the right side the transconnector would not seat. He loosened the nut on the left side to see if that would help, but it would not seat. He tried this a number of times, but it clearly wouldn? T seat properly. They used medium angled top loading transconnector but had the same result. When he was removing the 7. 5mm but it would not release and he said it felt as if the head of the pedicle screw splayed open. He decided to remove the transconnector nuts, locking screws and the transconnector and simply use just the standard titanium locking screws. He wants to know why the transconnector would not seat and if this has happened in the past. He said the center of the transconnector was not being held up by the lamina. There was a surgical delay of 15 minutes. The procedure was successfully completed. There was no patient consequences. Concomitant devices reported: transconnector locking set screw (part# unknown, lot# unknown, quantity unknown); titanium locking screws (part# unknown, lot# unknown, quantity unknown); transconnector nut driver (part# unknown, lot# unknown, quantity 1); pedicle screw (part# unknown, lot# unknown, quantity unknown); ti transconnector locking screw (part # 04. 614. 522, lot # unknown, quantity 3); ti transconnector locking nut 7. 5mm ( part # 04. 614. 521, lot # unknown, quantity 3); ti top loading transconnector medium (part # 04. 614. 516, lot #: 22p8031, quantity: 1). This report is for one (1) angled ti top loading transconnector/medium. This is report 5 of 5 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01276 |
| MDR Report Key | 9832580 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-14 |
| Date of Report | 2020-01-16 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2013-04-03 |
| Date Added to Maude | 2020-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGLED TI TOP LOADING TRANSCONNECTOR/MEDIUM |
| Generic Name | ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION |
| Product Code | NKG |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-01-30 |
| Model Number | 04.614.551 |
| Catalog Number | 04.614.551 |
| Lot Number | 7348874 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-14 |