MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE; INSTRUMENT, COMPRESSION

Catalog Number	03.111.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an unknown date in 2022.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 inspection of back up instruments on an unknown date, the depth gauge for 2.0mm and 2.4mm screws had a loose needle, two handle with mini quick coupling had issues locking driver shaft, two hold-sl ø2 f/compression/distraction dev did not lock wires, compression/distraction instrument turn knob kept popping off, comp/distraction instr for ulna osteo had a wire stuck inside the device, and a t-handle with quick coupling had a conical extraction screw stuck inside.There was no hospital involvement.This report is for a compression/distraction holding sleeve/2.0mm k-wire.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: part: 03.111.022.Lot: 2748954.Manufacturing site: oberdorf.Supplier: n/a.Release to warehouse date: august 24, 2011.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: COMPRESSION/DISTRACTION HOLDING SLEEVE/2.0MM K-WIRE
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BIO OBERDORF (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14288939
• Report Number: 2939274-2022-01617
• Device Sequence Number: 20214737
• Product Code: HWN
• UDI-Device Identifier: 07611819375826
• UDI-Public: (01)07611819375826
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 03.111.022
• Device Lot Number: 2748954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMP/DISTRACTION INSTR FOR ULNA OSTEO; COMPRESSION/DISTRACTION INSTRUMENT; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; HANDLE WITH MINI QUICK COUPLING; HANDLE WITH MINI QUICK COUPLING; HOLD-SL Ø2 F/COMPRESSION/DISTRACTION DEV; T-HANDLE WITH QUICK COUPLING
• Patient Sex: Unknown