MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-18 for T-PLIF IMPLANT HOLDER 389.266 manufactured by Wrights Lane Synthes Usa Products Llc.
[109002359]
There was no known reported patient involvement associated with the complained event. Device is an instrument and is not implanted/explanted. A device history record (dhr) review was performed for part number: 389. 266, synthes lot number: a7qa05, release to warehouse date: 31-jul-2007, manufacture site: (b)(4), part expiration date: n/a. List of nonconformance? S: n/a: a review of the both device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition. No non-conformance reports (ncrs) were generated during the production of this device. A product investigation was conducted. The t-plif implant holder (389. 266) is part of the t-plif instrument set to support the placement of t-plif spacers used in transforaminal posterior lumbar interbody fusion (t-plif) procedures. The applicable technique guide was reviewed. The t-plif approach is a unilateral alternative to the plif approach. The t-plif trial spacers and the t-plif implant holder are provided to ensure appropriate implant is selected and inserted into the disc space to restore disc height along with placement of bone graft around for optimal fusion. The implant holder enables slight impaction during insertion and t-plif impactors are used to fully seat the implant. The returned device was examined and both reported complaint conditions were able to be confirmed as a slotted screw was missing and one of the distal tips of the device was noted to be broken; neither piece was returned. Evidence of laser welding was noted where the missing screw would have been assembled, as such it is likely that the device was disassembled for sterilization and the screw was lost. No possible root cause was identified for the broken lower jaw tip; however this failure is typically associated with rough handling and/or the application of excessive force during use. Neither complaint condition was able to be replicated due to post-manufacturing damage. Relevant drawings for the returned device were reviewed. No dimensional analysis is applicable due to post-manufacturing damage. A design change for the lower jaw was initiated between drawing revisions where the radius (r2) near the distal tip was adjusted? To improve the performance against breaking at the suspect area? The radius helps reduce the stress at the suspect area by 25% (approximately)?. The returned device was manufacturing prior to the design change. A device history review, including material and hardness reviews, was performed for the returned instrument? S lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. 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
[109002360]
Device report from synthes reports an event in (b)(6) as follows: it was reported that during the cleaning process of the t-plif implant holder, a screw came off and the distal end tip arm came off on one side only. Malfunction occurred post-op. There was no patient involvement. During the manufacturer? S investigation of the returned device it was observed that the slotted screw was missing and one of the distal tips of the device was noted to be broken; neither piece was returned. This condition was re-evaluated and determined to be reportable on (b)(6) 2018. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-52241 |
| MDR Report Key | 7527658 |
| Date Received | 2018-05-18 |
| Date of Report | 2018-03-05 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2018-05-17 |
| Device Manufacturer Date | 2007-07-31 |
| Date Added to Maude | 2018-05-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T-PLIF IMPLANT HOLDER |
| Generic Name | FORCEPS,GEN & PLASTIC SURGERY |
| Product Code | GEN |
| Date Received | 2018-05-18 |
| Returned To Mfg | 2018-04-10 |
| Model Number | 389.266 |
| Catalog Number | 389.266 |
| Lot Number | A7QA05 |
| 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 | 2018-05-18 |