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

Catalog Number 292.620S

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2019

Event Type  Injury  

Manufacturer Narrative

Investigation summary: 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 history lot: this mre review is for sterilization procedure only.Part: 292.620s.Lot: 5l47817.Manufacturing site: (b)(4).Supplier: früh verpackungstechnik ag.Release to warehouse date: july 24, 2019.Expiry date: july 01, 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in (b)(4).Part: 292.620.Lot: 5l36012.Manufacturing site: (b)(4).Release to warehouse date: july 09, 2019.A manufacturing record evaluation was performed for the finished device lot number, 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 a 1.25 k-wire was broke as the cannulated screw was inserted over the wire and tip of wire left in patient¿s bone (distal tibia) as the broke off.It is above 2-3 cm the bone.The patient was stable.Concomitant device reported: unknown cannulated screw (part# unknown, lot# unknown, quantity# 1).This report is for 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.

• Brand Name: 1.25MM THREADED GUIDE WIRE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9209533
• MDR Text Key: 175657048
• Report Number: 8030965-2019-69465
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819733121
• UDI-Public: (01)07611819733121
• Combination Product (y/n): N
• PMA/PMN Number: PREAMEND
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 292.620S
• Device Lot Number: 5L47817
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CANNULATED
• Patient Outcome(s): Required Intervention