MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	02276075
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "during procedure, the reamer was broken".
Additional Manufacturer Narrative
Please refer to d9 - the product was returned for investigation, h6 component and method codes.The reported event could be confirmed, since the device was returned and matches the alleged failure.The provided im reamer shaft of the bixcut system shows extensive signs of usage.The reamer shaft is broken at the last windings near the reamer head (distal portion).The breakage surfaces show the typically rough and cliffy structure of a ductile overload fracture.The breakage pattern indicates torsional overloading under a stuck state and most likely due to which the reamer couldn¿t proceed further resulting in torsional overload and breakage.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.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.Based on the investigation, the root cause can be attributed to user-related as high torsional overload led to the breakage.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during procedure, the reamer was broken." additional information: all debris were removed from the patient.The procedure could be completed successfully.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19491793
• Report Number: 0009610622-2024-00272
• Device Sequence Number: 7089561
• Product Code: MAY
• UDI-Device Identifier: 04546540145796
• UDI-Public: 04546540145796
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 02276075
• Device Lot Number: K1578B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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 Age: 23 YR
• Patient Sex: Male
• Patient Weight: 90 KG