MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE Ø0.8 W/DOUB TIP L70 SST 10U; WIRE, SURGICAL

Catalog Number 292.480.10

Device Problem Material Deformation (2976)

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

Event Date 04/24/2023

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, a kirschner wire with double tip was opened at our hospital and it was reported that 5 out of 10 of these wires were clearly bent.Since the label was on the back of the package, it was impossible to find out if it was bent without opening the package and looking at the actual products.The person in charge checked the storage conditions in the hospital and found that some of the wires were bent and some were not.For the reasons stated above, it was reported that there was a problem from manufacturing to shipping.In addition, there is no use in any operations.No further information is available.This complaint involves five(5) devices.This report is for one (1) k-wire ø0.8 w/doub tip l70 sst 10u this is report 3 of 5 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.

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: a manufacturing record evaluation was performed for the finished device 292.480.10 lot #3924p76, and no non-conformances were identified.Part #: 292.480.10; lot #: 3924p76; manufacturing site: balsthal; release to warehouse date: 14-feb-2023.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the device was slightly bent.Based on the observed condition of the device, the investigation was able to confirm the reported allegation.This type of damage is attributed to transport/storage of the device.No other problem identified.A dimensional inspection was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 w/doub tip l70 sst 10u, p/n: 292.480.10, lot: 3924p76 would contribute to the complained device issue.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: K-WIRE Ø0.8 W/DOUB TIP L70 SST 10U
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL; dornacherstrasse 20; balsthal CO 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16892037
• MDR Text Key: 314905194
• Report Number: 8030965-2023-05918
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819321571
• UDI-Public: (01)07611819321571
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.480.10
• Device Lot Number: 3924P76
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 06/16/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: K-WIRE Ø0.8 W/DOUB TIP L70 SST 10U.; K-WIRE Ø0.8 W/DOUB TIP L70 SST 10U.; K-WIRE Ø0.8 W/DOUB TIP L70 SST 10U.; K-WIRE Ø0.8 W/DOUB TIP L70 SST 10U.