MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES

Catalog Number	323.029
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when device became stripped.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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.
Event or Problem Description
It was reported that during an unknown orthopedic procedure on (b)(6) 2018, the threaded locking compression plate (lcp) drill guide was stripped.The surgeon used a different screw in the drill guide for the procedure.It is unknown if there was a surgical delay.There was no patient consequence reported.This report is for a threaded lcp(tm) drill guide f/lcp(tm) distal radius plates.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: part: 323.029; lot: 2137771; manufacturing site: bettlach; release to warehouse date: september 07, 2005.The device history record shows this lot of 293 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.The instrument was received with the reported condition of ¿visual stripped/worn/twisted/cross threaded : nrm & device interaction (2+ devices) unable to assemble : rm¿ the following investigation flow was performed: damage: visual (appearance not as expected): visual inspection under 5x magnification revealed damage to the distal most 2 threads.The distal most 2 threads are no longer smooth/symmetrical.The balance of the device is in fair condition with signs of wear and tear.The received condition does agree with the complaint description.At customer quality, the returned instrument was inspected and the complaint condition was confirmed.Due to the post-market damage sustained by the returned part, a worthwhile dimensional check of relevant features could not be performed.A device history review was performed for the returned instrument¿s lot number and no material report reviews (mrrs), nonconformance reports (ncrs) or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing was reviewed and no issues were identified.The complaint condition of stripped was confirmed.A definitive root cause could not be determined, however the post-manufacturing damage on this 12+ year old reusable instrument is most likely a result of force/leverage applied to this device while not fully threaded into a plate.During the investigation, no product design or manufacturing issues were observed that 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.

• Brand Name: THREADED LCP(TM) DRILL GUIDE F/LCP(TM) DISTAL RADIUS PLATES
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7634330
• Report Number: 2939274-2018-52608
• Device Sequence Number: 1754961
• Product Code: FZX
• UDI-Device Identifier: 10886982190598
• UDI-Public: (01)10886982190598
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 323.029
• Device Lot Number: 2137771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1