MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, AO FITTING BIXCUT Ø11,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02256110
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a rupture of the instrument during surgery.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note corrections to section d9/h3, the device was not returned.The reported event could be confirmed with the help of a couple of images shared by the customer.The device inspection could not be performed as the device was not returned for evaluation.However, a couple of images were shared by the customer which shows the spiral to be in an unwound state, both at the distal as well as the proximal end.The spiral at the proximal end could be seen detached.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Since the actual device evaluation was not possible, the root cause of the issue could not be determined.However, based on the available images, most probable cause of the issue could be user related involving counter- clockwise rotation of the reamer during use, but not limited upto it.If the device is returned for evaluation or if any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that there was a rupture of the instrument during surgery.3/1/2024 - update.No impact to the patient.The surgery was completed with another replacement product.

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø11,0X480 MM
• 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: 18729695
• Report Number: 0009610622-2024-00077
• Device Sequence Number: 12809949
• Product Code: LXH
• UDI-Device Identifier: 04546540145390
• UDI-Public: 04546540145390
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

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: 02256110
• Device Lot Number: K02717A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2022
• 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 Sex: Unknown