MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE; MISC ROD,FIXATION,INTRAMEDULLARY

Model Number	04.033.270S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 open reduction internal fixation (orif) procedure due to a right side midshaft femur fracture on (b)(6) 2019, the surgeon had difficulty inserting the greater trochanter femoral recon nail.During the surgery, the canal was reamed 2.5 mm over the nail size but the surgeon still could not insert the nail.Subsequently, the entry point was evaluated and appeared to be perfect.The nail was hammered down, but it was approximately one-third of the way down, and not reaching the isthmus before the nail would impinge on both the lateral and medial cortex.However, it appeared on x-ray as if the distal third portion of the nail was too straight to get through the angle necessary with a greater troche entry.Eventually, the surgeon removed the nail and used a smaller diameter (11 mm) nail.The procedure was successfully completed with a thirty (30) minute surgical delay.There was no patient consequence reported.Concomitant devices reported; unknown insertion handle (part# /lot# unknown; quantity: unknown), unknown driving cap (part# /lot# unknown; quantity: unknown), unknown femoral nail (part# /lot# unknown; quantity: 1).This complaint involves one (1) devices.This report is for one (1) 12 mm / ti cann frn / gt 400 mm / right - sterile.This is report is 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: 12mm / ti cann frn / gt 400mm / right ¿ sterile was received at us customer quality (cq).Upon visual inspection at cq, it is observed that the device was bent.The surface of the device shows no physical damage.Thus, the complaint is confirmed.Device failure/ defect found? yes dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Document/specification review: respective drawings were reviewed during the investigation: no design issues or discrepancies were noted during the investigation.Complaint confirmed? yes investigation conclusion: a visual inspection, dimensional inspection, and document/specification review were performed as part of this investigation.The device was found to be bent.Thus, the complaint is confirmed.A definitive root cause for the reported problem is hammering the device.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based on these results, 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.Device history lot = > product code: 04.033.270s, lot #: l889901 manufacturing site: bettlach release to warehouse date: 28.May 2018 expiry date: pending a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: 12MM / TI CANN FRN / GT 400MM / RIGHT - STERILE
• Common Device Name: MISC ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9168744
• Report Number: 2939274-2019-61316
• Device Sequence Number: 19743684
• Product Code: HSB
• UDI-Device Identifier: 10886982271815
• UDI-Public: (01)10886982271815
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.033.270S
• Device Catalogue Number: 04.033.270S
• Device Lot Number: L889901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - IMPACTION INSTRUMENTS: TRAUMA; UNK - NAIL INSERTION HANDLES; UNK - NAILS: FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Weight: 101