MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE Ø1 L280 SST; WIRE, SURGICAL

Catalog Number 292.110.01

Device Problem Material Deformation (2976)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported at the time of the conference it was noted that the item was damaged.Material delivered was completely bent, as shown in the photo.This report is for one (1) k-wire ø1 l280 sst.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Procode: hty.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.A manufacturing record evaluation was performed for the finished device 292.110.01 lot # 446p891, 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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device photo.Visual analysis of the photo revealed that k-wire ø1 l280 sst the device had bent condition.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for k-wire ø1 l280 sst.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.

• Brand Name: K-WIRE Ø1 L280 SST
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14853459
• MDR Text Key: 303241371
• Report Number: 8030965-2022-04454
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319653
• UDI-Public: (01)07611819319653
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.110.01
• Device Lot Number: 446P891
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2022
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1