MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS INSERTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.010.046
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 unknown procedure on (b)(6) 2020, the percutaneous insertion handle has misaligned.The procedure was successfully completed without a surgical delay.Patient status was unknown.This complaint involves 1 device.This report is for 1 percutaneous insertion handle.This 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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device history lot part: 03.010.046, lot: l924043, manufacturing site: hägendorf, release to warehouse date: july 27, 2018.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.
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, h6: a product investigation was completed: upon visual inspection, there were some scratches and nicks observed on the device but have no impact on the device functionality.No other defects were identified with the returned device.A functional test was not performed on the returned device as the mating devices were not returned.A dimensional inspection was performed on the returned device and found to be within specification.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was not confirmed.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 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: PERCUTANEOUS INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10762173
• Report Number: 2939274-2020-04877
• Device Sequence Number: 19629439
• Product Code: LXH
• UDI-Device Identifier: 10886982067180
• UDI-Public: (01)10886982067180
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/02/2020

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: 03.010.046
• Device Catalogue Number: 03.010.046
• Device Lot Number: L924043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 11/05/2020; 11/25/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/27/2020; 12/01/2020
• Patient Sequence Number: 1