MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM CANNULATED DRILL BIT FLEXIBLE; BIT,DRILL

Model Number	03.033.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient's identifier: (b)(6).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 femoral nail surgery with femoral recon nail system (frn) on february 11, the impactor broke off of the insertion handle and a drill bit was broken off in the same exact surgery.It is unknown if there were fragments generated.Surgical delay of twenty (20) minutes was reported.The procedure was successfully completed.Patient outcome was unknown.Concomitant device reported: radiolucent insertion handle femoral recon nail (part#03.033.001, lot#l551415, quantity 1); driving cap/threaded (part # 03.010.523, lot # l504146, quantity 1).This report is for one (1) 14mm cannulated drill bit flexible.This is report 2 of 2 for complaint (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.H10 additional narrative: h6: part number: 03.033.004.Lot number: 26p1795.Manufacturing site: bettlach.Release to warehouse date: 22 november 2019.A manufacturing record evaluation was performed for the finished device with lot number 26p1795, and no non-conformances were identified.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided.The image was reviewed, and the complaint condition could be confirmed.After reviewing the image of the cannulated drill bit, it was seen that the drill bit was broken.Since the device was not returned, dimensional inspection and functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: 14MM CANNULATED DRILL BIT FLEXIBLE
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9800418
• Report Number: 2939274-2020-01170
• Device Sequence Number: 18996014
• Product Code: HTW
• UDI-Device Identifier: 10886982271082
• UDI-Public: (01)10886982271082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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 Model Number: 03.033.004
• Device Catalogue Number: 03.033.004
• Device Lot Number: 26P1795
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVING CAP/THREADED; RADIOLUCENT INSERTION HANDLE FRN
• Patient Age: 77 YR
• Patient Weight: 100