MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT SPS Ø3.2X145MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	700358
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2022
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.
Event or Problem Description
It was reported that the drill bit broke during surgery.Device disposed of by the customer.Update - "this relates to a drill bit which broke during use.The drill bit which snapped off was left in the patient.My understanding is that it was in the position of the 4th screw (of 4) on a plate and therefore would have been more challenging/impactful to the patient if the surgeon tried to remove it.At present, the patient will have been made aware of the event, and will presumably require monitoring for any delayed complications.".

• Brand Name: DRILL BIT SPS Ø3.2X145MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14192827
• Report Number: 0008031020-2022-00194
• Device Sequence Number: 4407989
• Product Code: LXH
• UDI-Device Identifier: 04546540110251
• UDI-Public: 04546540110251
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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: 700358
• Device Catalogue Number: 700358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown