MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT Ø2.5X230MM AO FITTING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	700355
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/27/2019
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 evaluated by mfr: device disposition unknown.
Event or Problem Description
The following was reported from medwatch (mw5085498); "procedure(s): orif left both column acetabulum fracture, orif left communicated sacral fracture via open posterior approach, removal of distal femoral traction ph.Surgeons used stryker drill bit when it broke off in the pt's bone (ilium).It was estimated that approx.2 cm remain in the pt.Surgeons were unable to retrieve it." no adverse consequences to the patient were reported.

• Brand Name: DRILL BIT Ø2.5X230MM AO FITTING
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8579694
• Report Number: 0008031020-2019-00385
• Device Sequence Number: 1587425
• Product Code: HWE
• UDI-Device Identifier: 04546540413789
• UDI-Public: 04546540413789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/03/2019

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: 700355
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1