MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705031
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposition unknown.
Event or Problem Description
The surgeon reported that he recently performed a contoured anterolateral distal tibial plate to a pilon fracture and that measuring directly after drill, the screws in the distal part of the tibia were in excess of a centimetre too long.These all had to be removed and replaced after using the direct measuring guide.The customer further reported that there are two sets of screw in guides and drills which are approximately 15 millimetres different in length and both marked with orange bands.The customer is concerned that with two different drills and drill guides it is possible for them to be mixed up and in this instance has wasted a number of screws, in addition to risking neurovascular structures by the implantation of screws that are too long.

• Brand Name: DRILL BIT AXSOS 3 TI LOCKING, SHORT, Ø3.1 X 216MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8081163
• Report Number: 0008031020-2018-00982
• Device Sequence Number: 19197373
• Product Code: LXH
• UDI-Device Identifier: 07613327083316
• UDI-Public: 07613327083316
• 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
• Report Date (Section B): 11/16/2018

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: 705031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/16/2018
• 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