MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø6.5X400MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	02275065
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
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.A review of the device history is not possible, because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported, that an im 6.5mm head reamer broke, during surgery.The reporter attributed the breakage to user applying excessive force at an aggressive angle.No complaints were made.And the patient was unharmed, with no operational delays or complications.The product involved was part of a loaner kit.And was discarded after use.The breakage occurred, during primary surgery for a hip fracture, with no debris left in the surgical field.The reamer was used to clear extra bone.And backup instruments were not needed.
Event or Problem Description
It was reported that an im 6.5mm head reamer broke during surgery.The reporter attributed the breakage to user applying excessive force at an aggressive angle.No complaints were made, and the patient was unharmed, with no operational delays or complications.The product involved was part of a loaner kit, and was discarded after use.The breakage occurred during primary surgery for a hip fracture, with no debris left in the surgical field.The reamer was used to clear extra bone, and backup instruments were not needed.
Additional Manufacturer Narrative
Correction to b2.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.However, it has been stated in the event description itself that the device broke due to user error.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø6.5X400MM
• 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: 20184598
• Report Number: 0009610622-2024-00832
• Device Sequence Number: 8930894
• Product Code: MAY
• UDI-Device Identifier: 04546540145772
• UDI-Public: 04546540145772
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 02275065
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown