MAUDE Adverse Event Report: STRYKER GMBH DRILL SLEEVE AXSOS 4.0MM LOCKING SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702707
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
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
The customer reported that an axsos locking drill guide snapped and that this was due to a user error.Additionally reported: the surgeon reported that he had used the guide as a handle to pass the plate through a smaller incision and it was at this point it had broken.He stated he has used this method with other kits in the past.No metal fell into the patient.
Additional Manufacturer Narrative
The reported event could be confirmed.Visual inspection: the visual inspection showed that the tip of the drill sleeve is indeed broken.The drill sleeve was used as a handle to pass the plate through a smaller incision, however, the drill guide is not intended for plate's insertion purposes.A review of the device history for the reported lot did not indicate any abnormalities.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.Based on investigation, the root cause was attributed to be a user related issue.The failure was caused by a misuse of the device.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported that an axsos locking drill guide snapped and that this was due to a user error.Additionally reported: the surgeon reported that he had used the guide as a handle to pass the plate through a smaller incision and it was at this point it had broken.He stated he has used this method with other kits in the past.No metal fell into the patient.

• Brand Name: DRILL SLEEVE AXSOS 4.0MM LOCKING SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9468131
• Report Number: 0008031020-2019-02154
• Device Sequence Number: 19369742
• Product Code: LXH
• UDI-Device Identifier: 07613154092666
• UDI-Public: 07613154092666
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 702707
• Device Catalogue Number: 702707
• Device Lot Number: J00428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1