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

Catalog Number	702459S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
After inserting the guide wire into the drill or - 702249, the guide wire broke within the drill in the bone.Could not remove the tip of broken and remain it in the patient.
Additional Manufacturer Narrative
The reported event that threaded guide wire asnis iii ø1.4x150mm was alleged of issue (breakage during surgery) could be confirmed, since the device was returned for evaluation and matched the alleged failure mode.The device inspection revealed the following: the returned threaded guide wire asnis iii ø1.4x150mm was found to be broken from the threaded portion.Marks are visible on the guide wire indicating the device was inserted tangentially or used repeatedly (multiple insertions).The breakage was most probably caused by excessive force applied on the device when inserting in a tangential direction.The batch record could not be reviewed because the lot number was not communicated and was not engraved on the returned device.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by excessive force applied on the device when inserting in a tangential direction/used repeatedly.The instruction for use informs the surgeon to be familiar with the recommended uses, compatibility and correct handling of the instrument.Also, the operative technique recommends the use of image intensification to control reduction and guide wire placement.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.
Event or Problem Description
After inserting the guide wire into the drill or - 702249, the guide wire broke within the drill in the bone.Could not remove the tip of broken and remain it in the patient.

• 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: 7691867
• Report Number: 0008031020-2018-00506
• Device Sequence Number: 1365331
• Product Code: LXH
• UDI-Device Identifier: 04546540381996
• UDI-Public: 04546540381996
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR