MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE Ø1.25 L150 SST; WIRE, SURGICAL

Catalog Number 292.120.01

Device Problem Failure to Cut (2587)

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

Event Date 09/10/2022

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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.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 Description

Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2022, that the drill bits are dull.Needle is scratched.They have no negative implications for the patient.This report is for one (1)k-wire ø1.25 l150 sst this is report 2 of 3 for complaint (b)(4).

• Brand Name: K-WIRE Ø1.25 L150 SST
• 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
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15505709
• MDR Text Key: 306327046
• Report Number: 8030965-2022-07532
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319660
• UDI-Public: (01)07611819319660
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.120.01
• Device Lot Number: 523P178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2022
• Initial Date FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female