MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS; TRAY,SURGICAL INSTRUMENT

Catalog Number	690.504
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted / explanted.The device was received and the product evaluation is in progress.No conclusion can be drawn.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 a field equipment inspection the locking screw rack was found dented.There is no patient involvement.Upon receipt of the device at manufacturer, it was noted that the coating on screw rack was chipping/peeling.This report is for one (1) locking screw rack for tibial nail-ex implants.This is report 1 of 2 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.Product investigation was completed.Visual inspection performed at customer quality (cq) confirmed the condition of a dented rack, which agrees with the reported complaint condition.Specifically, the entire case is bent/crushed/deformed/buckled in a manner that suggests it was either dropped or something fell on top of it.It was also observed that there are several areas of discoloration, nylon coating peeling from components/brackets and scratches.A review of the device history records was unable to be performed since the lot number was unknown.Relevant drawings no product design issues or discrepancies were observed.A dimensional inspection of features relevant to this complaint could not be obtained at cq due to the significant post manufacturing damage.This complaint is confirmed however no product design issues or manufacturing discrepancies were identified during this investigation.The significant post manufacturing damage suggests that the returned rack was subjected to rough handling/abuse for multiple years.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: LOCKING SCREW RACK FOR TIBIAL NAIL-EX IMPLANTS
• Common Device Name: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7584430
• Report Number: 2939274-2018-52447
• Device Sequence Number: 13833889
• Product Code: FSM
• UDI-Device Identifier: 10886982254184
• UDI-Public: (01)10886982254184
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 690.504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1