MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Model Number	03.010.441
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 an expert tibial nail insertion procedure on (b)(6) 2020, the drill bit made contact with nail while drilling for the proximal screw.The device was checked after the procedure and showed everything was correctly aligned.The procedure was successfully completed with 2 minutes surgical delay.There was no patient consequence.Patient status is unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for 1 aiming arm for suprapatellar.This is report 3 of 6 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.H3, h4, h6: part 03.010.441, lot 180064-103: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: may 23, 2018.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: AIMING ARM FOR SUPRAPATELLAR
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10943379
• Report Number: 2939274-2020-05439
• Device Sequence Number: 3169933
• Product Code: JDS
• UDI-Device Identifier: 10886982068835
• UDI-Public: (01)10886982068835
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2020

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: 03.010.441
• Device Catalogue Number: 03.010.441
• Device Lot Number: 180064-103
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/30/2020
• 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: 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; 12.0MM/8.0MM PROTECTION SLEEVE 188MM; 8.0MM/4.2MM DRILL SLEEVE 200MM; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - DRILL BITS: TRAUMA; UNK - SCREWS: TRAUMA; 11MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; 12.0MM/8.0MM PROTECTION SLEEVE 188MM; 8.0MM/4.2MM DRILL SLEEVE 200MM; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - DRILL BITS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Age: 33 YR