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 2020-02-03 for POLY SCREW DRIVER RETEN SLEEVE 2020-00-401 202000401 manufactured by Medos International Sàrl Ch.
[178228323]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. A product investigation was conducted. Visual analysis: the package for pc-#000617179 for part numbers 2020-33-400 and 2020-00-401 with lot numbers pc4585369 and pc4907029 respectively were returned for evaluation and examined by the quality engineer. Part number 2020-00-401 (retention sleeve) was found to have signs of normal use. Part number 2020-33-400 (x20 polydriver) was found to have signs of wear in the proximal annular groove feature. Additionally, the polydriver was found to have excessive debris near the proximal groove and along the outer surface of the shaft. Functional analysis: during the functional analysis of the x20 polydriver/retention sleeve, it was noted that the instruments did not function properly. Rotation and axial motion were locked. The x20 shaft was not able to be removed from the retention sleeve. Technical review: reviewing the tolerance analysis, it was found that when attaching the retention sleeve/x20 polydriver assembly to a poly screw and tightening, the internal ball bearings of the retention sleeve makes contact with the surface of the groove noted above. Document/specification review: based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed investigation conclusion: the complaint condition is confirmed for the poly screwdriver reten sleeve (p/n: 202000401, lot # pc4907029) as the x20 polydriver the polydriver was found to have excessive debris near the proximal groove and along the outer surface of the shaft, which could have contributed to the complaint condition. 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. Upon additional torque being applied to the retention sleeve, additional force is applied from the ball bearings to the groove surface, rolling the edge of the groove and creating a metallic burr. This burr hinders the insertion and removal of the x20 polydriver from the retention sleeve, creating drag. A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for poly screw driver reten sleeve was conducted identifying that lot number pc4907029 was released in a single batch. Batch1: lot qty of 49 units were released on 31 oct 2019 with no discrepancies. As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer. The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer. 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
[178228324]
It was reported that on (b)(6) 2019, during c2-t2 posterior cervical fusion the surgeon completed the surgery with depuy synthe spine symphony implants. When the scrub tech was disassembling the instruments after the surgery was successfully completed, she could not get the x20 poly screwdriver shaft to come apart from the retention sleeve. These 2 pieces are stuck together. The x20 poly screwdriver shaft that is deforming does not slide down the retention sleeve. The surgeon did use 4. 5mm diameter screws in t1 and t2 and the insertional torque was fairly high. There were no patient consequences. There was no surgical delay. No fragments generated. The procedure was successfully completed. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00485 |
| MDR Report Key | 9660141 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2019-12-09 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2019-10-31 |
| Date Added to Maude | 2020-02-03 |
| 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 | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INTERNATIONAL S |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 02400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLY SCREW DRIVER RETEN SLEEVE |
| Generic Name | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEA |
| Date Received | 2020-02-03 |
| Returned To Mfg | 2019-12-17 |
| Model Number | 2020-00-401 |
| Catalog Number | 202000401 |
| Lot Number | PC4907029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |