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 Date 10/26/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, after delivery and before the surgery, it was confirmed that the wires in question were bent.No further information is available.This report is for one (1) k-wire ø0.8 l150 sst 10u.This is report 1 of 1 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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a (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.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.H3, h4, h6 the products were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned devices.Visual analysis of the returned sample revealed that the ten (10) kirschner wires from the k-wire ø0.8 l150 sst 10u were bent from the distal section.No other defects were observed.A dimensional inspection was unable to be performed due to not being applicable to the complaint condition.Once the product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.It is more likely that the device was subject to unintended forces during distribution or storage/handling.However, no evidence of the device's outer packaging or delivery packaging was provided, therefore the potential cause of the reported condition cannot be established.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 k-wire ø0.8 l150 sst 10u, p/n: 292.090.10 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.Drawing/specifications reviewed se_250659 rev f current and manufactured dimensional inspection: n/a.Part number: 292.090.10, lot number: 6582p19, manufacturing site: balsthal, release to warehouse date: 02 aug 2023.A manufacturing record evaluation was performed for the finished device 292.090.10 lot number 6582p19, 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: 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): BALSTHAL; dornacherstrasse 20; balsthal CO 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18136056
• MDR Text Key: 328136105
• Report Number: 8030965-2023-14343
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819321366
• UDI-Public: (01)07611819321366
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 6582P19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1