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 Consequences Or Impact To Patient (2199)
Date of Event	10/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id also reported as (b)(6).The device has been 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 a suprapatellar nailing on (b)(6) 2020, part of the protection sleeve was either reamed or cut.The surgeon needed to open the patient further to retrieve the piece.It was also reported that the screw missed the nail through the aiming arm.Procedure was completed successfully with a delay of thirty (30) minutes.Patient status was very good.This report is for a aiming arm for suprapatellar.This is report 4 of 4 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: the aiming arm for suprapatellar (p/n: 03.010.441, lot #: 160450-102) was returned and received at us cq.Upon visual inspection, no issues were identified with the returned device.The complaint condition was not confirmed for the aiming arm for suprapatellar (p/n: 03.010.441, lot #: 160450-102).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that 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 : part: 03.010.441, lot: 160450-102, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 24.Feb.2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch : null.Device history review : 11-nov-2020 by: mschoenfeld a dhr review could not be performed for this pi.There is no record of this part number or lot number being manufactured at the monument facility.Please reassign this task to the correct group.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: 10820507
• Report Number: 2939274-2020-05096
• Device Sequence Number: 13734922
• Product Code: JDS
• UDI-Device Identifier: 10886982068835
• UDI-Public: (01)10886982068835
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2020

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: 03.010.441
• Device Catalogue Number: 03.010.441
• Device Lot Number: 160450-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/11/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: 14.5MM OUTER PROTECTION SLEEVE; 14.5MM OUTER PROTECTION SLEEVE; CANN CONNECTING SCREW; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - NAILS; UNK - SCREWS: TRAUMA
• Patient Age: 45 YR
• Patient Weight: 100