MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT 8,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	0227-6080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
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.
Event or Problem Description
The incident occurred during insertion of the intramedullary nail into the femur.The medullary canal of the femur was drilled with a uniform reamer with a diameter of 8.0 mm along the guide.After reaching the optimal drilling length, the reamer was withdrawn.The reamer came out, however, its distal fragment, approx.3-4 cm long, remained at the end of the guide in the medullary canal.The guide was removed along with the damaged part of the reamer.Subsequently, further widening of the medullary canal was started using larger size reamers.There was no part of the reamer left in the patient's body - it was removed along with the guide.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT 8,0X480MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10681046
• Report Number: 0009610622-2020-00564
• Device Sequence Number: 19606534
• Product Code: MAY
• UDI-Device Identifier: 04546540145802
• UDI-Public: 04546540145802
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K153345
• 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): 10/14/2020

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: 0227-6080
• Device Catalogue Number: 02276080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1