MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM K-WIRE INSERT; GUIDE

Model Number	324.084
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, prior to an unknown procedure, it was noticed that a sleeve was damaged.As the surgical nurse tried to forcefully pass a wire, it was bound up and cold welded to the sleeve.There was no patient impact since this was prior to the surgery.Concomitant device reported: unk - cable/wire: trauma: (part# unknown; lot# unknown; quality:1) this complaint involves one (1) device.This report is for (1) 1.25mm k-wire insert this report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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 on (b)(6) 2021, prior to an unknown procedure, it was noticed that a sleeve was damaged.As the surgical nurse tried to forcefully pass a wire, it was bound up and cold welded to the sleeve.There was no patient impact since this was prior to the surgery.Concomitant device reported: unk - cable/wire: trauma: (part# unknown; lot# unknown; quality:1) this complaint involves one (1) device.This report is for (1) 1.25mm k-wire insert this report is 1 of 2 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: this complaint is confirmed as the device was deformed/bent and was not able to disassemble as intended.The potential cause for the device interaction condition could be due to the deformed and bent condition of the device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: 324.084.Lot: l415214.Manufacturing site: bettlach.Supplier: n/a.Release to warehouse date: 23 may 2017.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot 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.

• Brand Name: 1.25MM K-WIRE INSERT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13204964
• Report Number: 2939274-2022-00086
• Device Sequence Number: 4744698
• Product Code: FZX
• UDI-Device Identifier: 10886982191113
• UDI-Public: (01)10886982191113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,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 Model Number: 324.084
• Device Catalogue Number: 324.084
• Device Lot Number: L415214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE
• Patient Sex: Unknown