MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT Ø10,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0225-6100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/11/2020
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 discarded.
Event or Problem Description
The surgeon reported that during a t2 ankle procedure, the tip of the fixed head reamer broke off and the tip remains in the patient's tibia.The surgeon was not using a vaulted guidewire when reaming.

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø10,0X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9684863
• Report Number: 0009610622-2020-00044
• Device Sequence Number: 11548863
• Product Code: LXH
• UDI-Device Identifier: 04546540145376
• UDI-Public: 04546540145376
• 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): 02/07/2020

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: 0225-6100
• Device Catalogue Number: 02256100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1