MAUDE Adverse Event Report: SYNTHES GMBH 3.2MM GUIDE WIRE 400MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 357.399

Device Problem Noise, Audible (3273)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 10/02/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, the surgeon was frustrated that the 3.2mm guide pin perforated the femoral head while drilling for a lag screw.It's possible that the 3.2 wire bound up inside of the drill bit because the surgeon commented that it was making a noise before pushing the guide pin in through the femoral head.The lag screw was then inserted and the surgery was successfully completed.No surgical delay was reported.No additional information was reported.This report involves one 3.2mm guide wire 400mm.This is report 1 of 1 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.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: 3.2MM GUIDE WIRE 400MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15658586
• MDR Text Key: 302270532
• Report Number: 8030965-2022-08799
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982196248
• UDI-Public: 10886982196248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 357.399
• Device Catalogue Number: 357.399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2022
• Initial Date FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNK - DRILL BITS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male