MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS/DCS COUPLING SCREW; EXTRACTOR

Model Number 338.31

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

Additional patient identifier: (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 Description

It was reported that on (b)(6) 2020, during an unknown procedure, when the surgeon was inserting the unknown dynamic hip and condylar screw system (dhs/ dcs) lag screw over the unknown 2.5mm t-handle, the coupling screw prevented the wire from passing through and pushed the wire into the patient's pelvis/ lower abdomen.Immediately upon x-ray review, the surgeon removed the unknown lag screw but the wire remained behind.The surgeon was able to finish the procedure free-handed without the instruments.There was a surgical delay of twenty (20) minutes to get the wire out.Upon review of instrumentation after the case, the coupling screw seemed to be stripped or marred and prevented the wire from passing through.The patent was doing well and the procedure outcome was as desired at the end of the case.Concomitant devices reported: unknown dhs lag screw (part# unknown, lot# unknown, quantity 1).Unknown 2.5mm t-handle (part# unknown, lot# unknown, quantity 1).Unknown dhs plate (part# unknown, lot# unknown, quantity 1).Unknown cable/wire: orthopaedic cable (part# unknown, lot# unknown, quantity 1).This report is for one (1) dhs®/dcs® coupling screw.This is report 1 of 2 for complaint (b)(4).

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: h3, h4, h6: part 338.31, lot ft00302: release to warehouse date: february 22, 2017.Supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: a product investigation was completed: the distal tip was found to be slightly stripped and there were some scratches on the device.No other issues were identified with the returned device.The functional test could not be performed on the returned device as no mating parts were received.The outer diameter of the shaft at the broken end was measured and was within the specification.Based on the date of manufacture the drawings, reflecting the current and manufactured revision were reviewed.The complaint condition is confirmed as the device tip was found to be stripped and there were scratches on the device.The stripped threads could have contributed to the device interaction issue.No definitive root-cause can be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: DHS/DCS COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11091291
• MDR Text Key: 224311832
• Report Number: 2939274-2020-05760
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982193322
• UDI-Public: (01)10886982193322
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Model Number: 338.31
• Device Catalogue Number: 338.31
• Device Lot Number: FT00302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - CABLE/WIRE: ORTHOPAEDIC CABLE; UNK - HANDLES: TRAUMA; UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW; UNK - PLATES: DHS/DCS
• Patient Age: 88 YR