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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2020, during an unknown procedure, the driving cap broke off inside the insertion handle and the aiming arm fell on the floor and broke off.The flexible shaft has malfunctioned, and the unknown reamer head broke off into the patient.The surgeon used a backup set to complete the procedure.There was a surgical delay of 5 minutes.The fragments of the broken device were generated.Concomitant devices reported: 5.0mm flexible shaft 620mm (part number 352.044, lot unknown, quantity 1), driving cap (part number 03.010.475, lot unknown, quantity 1), insertion handle for suprapatellar (part number 03.010.440, lot unknown, quantity 1), impaction instruments: trauma (part number unknown, lot unknown, quantity 1), reamers: reamer head (part number unknown, lot unknown, quantity 1).This report involves 1 aiming arm for suprapatellar.This is report 4 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.H10 additional narrative: e1: initial facility information updated.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: 11023084
• Report Number: 2939274-2020-05620
• Device Sequence Number: 17242331
• Product Code: JDS
• UDI-Device Identifier: 10886982068835
• UDI-Public: (01)10886982068835
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/01/2021
• 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: 5.0MM FLEXIBLE SHAFT 620MM; DRIVING CAP; IMPACTION INSTRUMENTS; INSERT HANDLE FOR SUPRAPATELLAR; REAMERS: REAMER HEAD