MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE Ø0.8 L150 SST 10U; WIRE, SURGICAL

Catalog Number 292.090.10

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the k-wire in question had been bent already when it arrived at the hospital.This k- wire was not used in surgery.This k- wire was delivered as a replacement for the previous defective product captured in (b)(4).This report is for one (1) k-wire ø0.8 l150 sst 10u.This is report 7 of 10 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.Additional narrative: device is not distributed in the united states, but is similar to device marketed in the usa.The subject 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.

• Brand Name: K-WIRE Ø0.8 L150 SST 10U
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15674956
• MDR Text Key: 302434283
• Report Number: 8030965-2022-08956
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819321366
• UDI-Public: (01)07611819321366
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 292.090.10
• Device Lot Number: 803P222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1