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

Catalog Number 292.620

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

Patient Problem Foreign Body In Patient (2687)

Event Date 11/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial reporter is synthes sales representative.Pre-amendment k-wires.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 during a tibia osteosynthesis procedure on (b)(6) 2018, the trocar guide wire was perforated on the fractured bone.The perforated part of the trocar guide wire was left in the bone for possible extraction.The orthopedist reported that the guide wire/pin will not affect the patient.The procedure was successfully completed with no complications.Concomitant device reported: unknown cannulated screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for pc-(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.Date received by manufacturer date reported on previous follow-up was 11/30/2018, actual date is 1/30/2019.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.A review of the device history records: part number: 292.620.Lot number: 1l18781.Part manufacture date: n/a.Manufacturing location: n/a.Part expiration date: n/a.Nonconformance noted: n/a.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira.Device history batch null, device history review a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid for elmira.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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8102143
• MDR Text Key: 128289128
• Report Number: 8030965-2018-58453
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841
• 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,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620
• Device Lot Number: 1L18781
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Patient Sequence Number: 1
• Patient Age: 24 YR