MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø11,0X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276110
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	07/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "i have just been contacted by the (b)(6) account and they have informed me that a bixcut reamer has snapped inside the patient.The coil part of the reamer uncoiled during use whilst using a guidewire, removed and x-rayed patient nothing remained in patient.".
Event or Problem Description
As reported : "i have just been contacted by the sath account and they have informed me that a bixcut reamer has snapped inside the patient.The coil part of the reamer uncoiled during use whilst using a guidewire, removed and x-rayed patient nothing remained in patient.Patient required longer anesthetic.A 30 minute delay was reported.".
Additional Manufacturer Narrative
Correction - please refer to b1 adverse event/product problem, d9 product available to stryker.The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received device was visually inspected, and we can see clear breakage of the reamer head from the shaft at the welded section which terms to the application of the excessive torsional and axial load on the process.The breakage surfaces show the typically rough and cliffy structure of a ductile overload fracture.We can also see that the spiral shaft is open at various positions, indicating that the reamer was also used in a counterclockwise direction.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 based on the investigation the root cause can be establish as normal wear and tear as the device was manufactured in 2004 and over time wear and tear gradually diminishes a device's strength, leading to reduced performance and increased susceptibility to failure, which resulted in failure due to overload of force.If any further information is provided the complaint report will be updated.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø11,0X480MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 19972531
• Report Number: 0009610622-2024-00787
• Device Sequence Number: 12852787
• Product Code: LXH
• UDI-Device Identifier: 04546540145864
• UDI-Public: 04546540145864
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153345
• 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): 10/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 02276110
• Device Lot Number: K600052
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2004
• 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: Required Intervention
• Patient Sex: Unknown