MAUDE Adverse Event Report: STRYKER GMBH THREADED GUIDE WIRE ASNIS III Ø3.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702462
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
The surgeon reported that as he was using the measuring device with a guide wire, the device did not appear to be measuring correctly and it resulted in the surgeon choosing a screw that was too long.The screw was removed and replaced with a shorter screw.The surgeon is not sure whether the measuring device, k-wire or screw are at issue.The kit has been in use at this facility for some years without any other issues being reported for measuring function.There was a delay, (length of delay unknown) but this was less that 30 minutes.
Additional Manufacturer Narrative
Correction: section d4 (lot #).The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number that was communicated in this case does not yield any positive matches in our database.A manual search of a similar lot number was unsuccessful as well.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
The surgeon reported that as he was using the measuring device with a guide wire, the device did not appear to be measuring correctly and it resulted in the surgeon choosing a screw that was too long.The screw was removed and replaced with a shorter screw.The surgeon is not sure whether the measuring device, k-wire or screw are at issue.The kit has been in use at this facility for some years without any other issues being reported for measuring function.There was a delay,(length of delay unknown) but this was less that 30 minutes.

• Brand Name: THREADED GUIDE WIRE ASNIS III Ø3.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9809075
• Report Number: 0008031020-2020-00655
• Device Sequence Number: 2770027
• Product Code: LXH
• UDI-Device Identifier: 04546540112149
• UDI-Public: 04546540112149
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 05/13/2020

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 Model Number: 702462
• Device Catalogue Number: 702462
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1