MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02276080
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was returned for evaluation was found to be deformed not broken as per reported event.The received device was visually inspected, and we found that the spiral shaft is deformed from its original shape.The shaft is bent on one side, we also see usage marks on the device in the form of spiral rings which form while the device rubs with the other component.The reamer cutting flutes are also show signs of nick marks and dull in nature.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 established a combination of user related and normal wear and tear and we can see deformation and dullness around the reamer.If any further information is provided the complaint report will be updated.
Event or Problem Description
As reported: "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." case type: im fixation of the tibia the procedure was completed with 30 min of delay by using another set of instruments.
Additional Manufacturer Narrative
Correction: please refer to h6 device code.
Event or Problem Description
As reported: "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." case type: im fixation of the tibia.The procedure was completed with 30 min of delay by using another set of instruments.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM
• 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: 20226409
• Report Number: 0009610622-2024-00835
• Device Sequence Number: 7240643
• Product Code: LXH
• UDI-Device Identifier: 04546540145802
• UDI-Public: 04546540145802
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/27/2024

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: Health Professional
• Device Catalogue Number: 02276080
• Device Lot Number: K445977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2009
• 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