MAUDE Adverse Event Report: SYNTHES GMBH K-WIRE Ø1.6 L150 SST; WIRE, SURGICAL

Catalog Number 292.160.01

Device Problem Scratched Material (3020)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a j&j employee.Device is not distributed in the united states, but is similar to device marketed in the usa.A device history record (dhr) review was conducted: visual inspection: the k-wire ø1.6 l150 sst (p/n: 292.160.01, lot number: 71p4601) was received at us cq.Visual inspection of the complaint device showed the distal tip of the device was deformed.However, the reported condition for the scratched could not be confirmed.No other issues were observed with the complaint device.Dimensional inspection: dimensional inspection was performed for the design of device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the device was received distal tip deformed, but the reported condition for scratches could not be confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.Investigation summary: the complaint device (k-wire ø1.6 l150 sst) was not received for investigation.A photo investigation was performed based on the file attached in notes & attachments section of pc titled ¿source file - (b)(4).The images were reviewed, and the complaint condition is not confirmed.The device does not appear to have any scratches or defect due to poor quality photo and there is no damage visible from what can be seen of the complaint part.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history review: a manufacturing record evaluation was performed for the finished device 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021, the screw head was battered and the needle was scratched at the tip, which then was not used in the surgery.This report is for (1) k-wire ø1.6 l150 sst.This is report 2 of 2 for complaint (b)(4).

• Brand Name: K-WIRE Ø1.6 L150 SST
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13289495
• MDR Text Key: 289507099
• Report Number: 8030965-2022-00399
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819319707
• UDI-Public: (01)07611819319707
• 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,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: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.160.01
• Device Lot Number: 71P4601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 10