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

Catalog Number 292.620S

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

Additional procode: hty.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during an open reduction internal fixation (orif) of the patient's finger, two (2) guidewires broke and the threaded tip remained in the patient.There was a surgical delay of ten (10) minutes.There was no surgical intervention.There is no further information available.This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 2 of 2 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.H3, h4, h6: sterile part (b)(6), lot 8l13703: part manufacture date: april 28, 2021.Part expiration date: april 01, 2031.Manufacturing site: selzach.Supplier: (b)(6).Non-sterile part (b)(6), lot 99p0652: release to warehouse date: april 20, 2021.Manufacturing site: balsthal.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.A review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.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

The operation was completed successfully.

• 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: 12078003
• MDR Text Key: 268299197
• Report Number: 8030965-2021-05373
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• Device Lot Number: 8L13703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 07/30/2021
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1.