MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, AO FITTING BIXCUT Ø10,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02256100
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during osteosynthesis surgery of the femur with gamma nail, there occurs reamer breaking.The procedure was completed with the use of other instruments.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The reamer was received broken into fragments and another broken fragment was not returned.Inspection of the breakage section of the spiral shaft indicates that the device breakage happened in a brittle manner with the application of higher torsional force in a counterclockwise manner causing the spiral to unwind up.We can also see slight discoloration on the spiral, indicating wear and tear over the usage period.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 attributed to wear related as the device was manufactured in 2012 device has gone through multiple usage and sterilization cycles which led to a decrease in the material strength of the product and breakage during usage due to application of high torsional force.However, stryker t&e typically does not specify the maximum number of uses appropriate for a reusable medical device.When cleaned, sterilized and maintained according to the instructions provided within this document, the reusable medical device basically maintains its function and biocompatibility over the lifetime of the device.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during osteosynthesis surgery of the femur with gamma nail, there occurs reamer breaking.The procedure was completed with the use of other instruments." 10/22/2024 - additional information received: the surgical delay is not quantifiable, as it is related to the problem resolution.No consequences for the patient.The guide wire was used with the affected instrument to insert the intramedullary nail.The device was not damaged when opened and any debris was removed immediately.

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø10,0X480 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: 20462902
• Report Number: 0009610622-2024-00868
• Device Sequence Number: 20781974
• Product Code: LXH
• UDI-Device Identifier: 04546540145376
• UDI-Public: 04546540145376
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 02256100
• Device Lot Number: K584176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2012
• 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: 32 YR
• Patient Sex: Unknown