MAUDE Adverse Event Report: STRYKER GMBH THREADED GUIDE WIRE ASNIS III Ø1.4X150MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702459S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Left in the patient and remaining wire was discarded.
Event or Problem Description
It was reported that the surgeon was using 4mm cannulated screws for a foot fracture.When taking final x-rays it was observed that the tip of one of the guide wires had snapped off either during pre-drilling or screw insertion (unknown which).It was decided by the surgeon that this would not affect the outcome of the patient and therefore it was left in the bone.The remaining length of wire was approximated to be no more than 3mm.The procedure was completed successfully, and no adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation (conversation with sales representative), the root cause was attributed to be user related.The failure was caused by too much applied force during use (last case of day, was in a rush).Surgeon and rep felt wire was put in quickly and snapped as a result of the speed.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the surgeon was using 4mm cannulated screws for a foot fracture.When taking final x-rays it was observed that the tip of one of the guide wires had snapped off either during pre-drilling or screw insertion (unknown which).It was decided by the surgeon that this would not affect the outcome of the patient and therefore it was left in the bone.The remaining length of wire was approximated to be no more than 3mm.The procedure was completed successfully, and no adverse consequences or surgical delay were reported.

• Brand Name: THREADED GUIDE WIRE ASNIS III Ø1.4X150MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8528432
• Report Number: 0008031020-2019-00364
• Device Sequence Number: 16243300
• Product Code: LXH
• UDI-Device Identifier: 04546540381996
• UDI-Public: 04546540381996
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 702459S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1