MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	0227-6110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that during a gamma3 nail procedure, the bixcut reamer broke in the patient.All pieces were retrieved from the patient.The customer indicated that this device had been replaced in (b)(6) 2020.Update 05/05/2021: patient was being treated for primary, trochanteric hip fracture normal bone quality no images or x-rays are available.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition is uknown.
Event or Problem Description
It was reported that during a gamma3 nail procedure, the bixcut reamer broke in the patient.All pieces were retrieved from the patient.The customer indicated that this device had been replaced in (b)(6) 2020.Update 05/05/2021: patient was being treated for primary, trochanteric hip fracture.Normal bone quality.No images or x-rays are available.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM
• 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: 11824310
• Report Number: 0009610622-2021-00513
• Device Sequence Number: 19910509
• Product Code: MAY
• UDI-Device Identifier: 04546540145864
• UDI-Public: 04546540145864
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 0227-6110
• Device Catalogue Number: 02276110
• Device Lot Number: K0E27C9
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR