MAUDE Adverse Event Report: SYNTHES GMBH 1.0MM KIRSCHNER WIRE, TROCAR POINTS ON BOTH ENDS 150MM; WIRE, SURGICAL

Catalog Number VW1004.15.10

Device Problem Material Deformation (2976)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in sweden as follows: it was reported that all items delivered to customer were bent.Devices have not been used for surgery.There was no patient or procedure involvement.This report is for one (1) 1.0mm kirschner wire, trocar points on both ends 150mm this is report 1 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1, a2, a3, a4, g4, 510k#: device is a veterinary product.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a distributor.H3, h6: 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.

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.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that all ten (10) wires of the vet k-wire ø1 w/doub tip l150 sst 10u (lot number: 8083p94) were bent across the middle section.With the provided information and the fact that the device was not returned with the original packaging, a root cause cannot be established for the observed condition of the wires.A dimensional inspection for the vet k-wire ø1 w/doub tip l150 sst 10u was unable to be performed due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the vet k-wire ø1 w/doub tip l150 sst 10u would contribute to the complained device issue.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.H3, h6: device history record (dhr) review conducted: part: 02.221.094s; lot no: 8083p94; release to warehouse date: 04 oct,2023; manufacturing site: werk selzach; supplier: (b)(4).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: 1.0MM KIRSCHNER WIRE, TROCAR POINTS ON BOTH ENDS 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18211945
• MDR Text Key: 329824652
• Report Number: 8030965-2023-14853
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819502642
• UDI-Public: (01)07611819502642
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• 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

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VW1004.15.10
• Device Lot Number: 8083P94
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2023
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1