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

Catalog Number 292.120.01

Device Problem No Apparent Adverse Event (3189)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in colombia as follows: it was reported that on september 29, 2023, the device twisted during surgery.There was no patient harm.Upon inspection of the returned devices on december 6, 2023, it was noted that two k-wires were also bent.This report involves one k-wire ø1.25 l150 sst.This is report 2 of 3 for (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: e3: reporter is a j&j employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: 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 k-wire ø1.25 l150 sst was bent from the distal section.No other defects were observed.A dimensional inspection was not performed for the k-wire ø1.25 l150 sst due to post manufactured damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to excessive / unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Through follow up it is now understood there is no allegation associated against a product malfunction.However, a defect was found in the device during the visual inspection.There is no indication that a design or manufacturing issue has caused the observed 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.Device history review (dhr): part number: 292.120.01 lot number: 3927p43 manufacturing site: balsthal release to warehouse date: 20-feb-2023 a manufacturing record evaluation was performed for the finished device 292.120.01 lot number 3927p43, 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 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 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18391652
• MDR Text Key: 331302018
• Report Number: 8030965-2023-16117
• Device Sequence Number: 1
• Product Code: LRN
• 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

• Date FDA Received: 12/26/2023
• 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: 3927P43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRILL BIT Ø2 W/DOUBLE MARKING L140/115 3.; K-WIRE Ø1.25 L150 SST.