MAUDE Adverse Event Report: SYNTHES GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL

Catalog Number 292.62

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Additional device product code: lrn.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j employee.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 surgeon used a threaded guide wire for a 4.0mm cannulated screw insertion.After inserting the threaded guide wire, surgeon wanted to remove it, but upon removal the guide wire broke across the patella.Surgeon tried removing the guide wire again and it continued breaking in to smaller pieces.Surgeon went medially to pull it out but the wire kept breaking and had to leave the wire across the patella.Surgeon then used a k-wire and placed a screw beneath.No further information provided.This report is for one (1) 1.25mm threaded guide wire 150mm.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.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: part: 292.620, lot: 80p2637, release to warehouse date: december 18, 2020, a manufacturing record evaluation was performed for the finished device 292.620 lot number 80p2637, and no non-conformances were identified.Visual inspection the guide wire ø1.25 w/thread-tip w/trocar l1 was returned and received at us customer quality (cq).A visual inspection was performed the distal tip was observed to be broken and broken piece was returned.The embedded piece cannot be confirmed as there was no evidence (photos or x-rays) provided showing that the fragments were embedded in the patient.No other issues were identified with the returned device.Document/specification review the current and manufacturing drawings were reviewed.Investigation conclusion the complaint condition for the guide wire ø1.25 w/thread-tip w/trocar l1 was confirmed as device was broken.However, the embedded device allegation was not confirmed as there were no photos or x-rays provided.While no definitive root cause could be determined, it is possible that the excessive torque/force was used during screw insertion, resulting in the twisted tip.During the investigation, no product design issues, or discrepancies were observed 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11582255
• MDR Text Key: 243106948
• Report Number: 8030965-2021-02391
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.62
• Device Lot Number: 80P2637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Date Manufacturer Received: 06/16/2021
• Patient Sequence Number: 1
• Treatment: K-WIRE Ø1.25 L150 SST; UNK - SCREWS: 4.0 MM CANNULATED
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR