MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 1.1MM THREADED GUIDE WIRE 150MM

Catalog Number 292.622S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted / explanted.Subject device has been received and is currently in the evaluation process.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 europe reports an event in (b)(6) as follows: it was reported the 1.1mm threaded guide wire was used in a procedure for a humeral fracture on (b)(6) 2017.After surgeon inserted the 3.0mm cannulated cancellous screw (ccs) through the guide wire, the threaded tip portion of the guide wire broke.The broken fragment could not be retrieved and remains embedded in patient¿s bone.Surgeon stated that when he inserted the guide wire until just before contralateral cortical bone, it was possible for the guide wire to bow.He suspects that it was when he was pulling it out when the guide wire was broken.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A device history record review was performed for the subject device.Part number: 292.622s.Synthes lot number: l468058.Release to warehouse date: 28.Jun.2017 expiry date: 01.Jun.2027.(b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile: part number: 292.622.Synthes lot number: l445596.Release to warehouse date: 01.Jun.2017.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device: our investigation shows obviously signs of wear and tear allover on the surface as well as striation marks.Furthermore, we found the guide wire broken at the threaded area.The broken part is missing.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.As indicated in the manufacturing documents the correct material (316l) was used.The microscopic view, with a magnification of 10x, of the broken surface shows a homogeneous surface what indicates material conformity as well.Unfortunately, we are not able to determine the exact cause of the breakage.We do suppose that the cause of the breakage is the result of a mechanical overload situation during use.Because of the damage and the missing part, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's.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: 1.1MM THREADED GUIDE WIRE 150MM
• Type of Device: GUIDE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7177317
• MDR Text Key: 96842661
• Report Number: 8030965-2018-50208
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 07611819733138
• UDI-Public: (01)07611819733138(17)270601(10)L468058
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.622S
• Device Lot Number: L468058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Date Manufacturer Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1