MAUDE Adverse Event Report: SYNTHES GMBH VET K-WIRE Ø1 W/DOUB TIP L150 SST 10U; WIRE, SURGICAL

Catalog Number VW1004.15.10

Device Problem Material Deformation (2976)

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

Event Date 10/18/2023

Event Type  malfunction  

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.No patient information will be reported.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter phone number: (b)(6).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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: vw1004.15.10.Lot no: 8083p94.Release to warehouse date: 04 oct 2023.Manufacturing site: werk selzach.Supplier: depuy synthes products, inc.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

Device report from sweden reports an event as follows: it was reported that on 18-october-2023, the k-wire in question was found to be bent inside of the box upon delivery.There was no damage to the outer box.The issue was discovered in the warehouse, there was no patient or procedure interaction.No further information is available.This report is for a vet k-wire ø1 w/doub tip l150 sst 10u.This is report 1 of 4 for (b)(4).

• Brand Name: VET K-WIRE Ø1 W/DOUB TIP L150 SST 10U
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18074288
• MDR Text Key: 327416745
• Report Number: 8030965-2023-13946
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1