MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT, T8, AO QUICK COUPLING ANCHORAGE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	XTV008001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2020
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.Device is not available; disposed by hospital.
Event or Problem Description
As reported: "using mmi anchorage mtp cp plate, while using the distal locking guide a 2.0mm drill bit tip broke off in the patient and we were unable to recover it.Along with the drill bit while screwing in the last 3.5mm locking screw the t8 screwdriver tip broke off in the screw head unable to get loose and out of the screw head.Both drill bit and screwdriver head stuck in the screw were left in the patient and surgical site closed." no delay¿s or major distraction to the case.

• Brand Name: SCREWDRIVER BIT, T8, AO QUICK COUPLING ANCHORAGE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10573141
• Report Number: 0008031020-2020-02260
• Device Sequence Number: 11639778
• Product Code: LXH
• UDI-Device Identifier: 07613252266952
• UDI-Public: 07613252266952
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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): 09/23/2020

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: XTV008001
• Device Catalogue Number: XTV008001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1