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	Crack (1135); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "mechanical damage of reamers during reaming of tibial bone.Every next reamer were blocking in marrow cavity.They were used according to instruction for use, starting from the smallest.In the end replacement device from different company has been used.Nothing left in patient body." 12/19/2024 - additional information received: deformation of the device, device was changed due to possibility of breaking.All instruments used to drill were compatible with bixcut reamers.There were used stryker¿s power tools with all appropriate attachments.
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: "mechanical damage of reamers during reaming of tibial bone.Every next reamer were blocking in marrow cavity.They were used according to instruction for use, starting from the smallest.In the end replacement device from different company has been used.Nothing left in patient body." 12/19/2024 - additional information received: deformation of the device, device was changed due to possibility of breaking.All instruments used to drill were compatible with bixcut reamers.There were used stryker¿s power tools with all appropriate attachments.
Additional Manufacturer Narrative
Corrections: please refer to section d2a, d2b and h6 health impact code.The reported event could be confirmed based on the inspection of the returned reamer.The device inspection revealed the following: the identification of the returned reamer could be confirmed based on the catalog # and the lot # marked.The tip of the instrument is bent, as reported.Furthermore, a crack, resulting from excessive bending load, can be observed in the chamfer between the tip and the flexible shaft.The flutes of the instrument are heavily worn out, much more than what is usually observed for an 8-month-old reamer.Dimensional and material integrity inspection showed the device to be within specification.Based on investigation, the root cause was attributed to an user related issue.The damage observed on the reamer is most probably a result of excessive bending load combined with excessive drilling speed.The extent of the damage observed is unusual for an 8-month-old device, which has only been used 10 to 15 times (as reported by the user).This indicates that the reamer has been handled carelessly.No statement regarding hard bone has been given by hcp and no x-rays were received.Therefore, it is not possible to make any statement of a possible influence of the patient's bone condition on the damage of the reamer.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.If more information is provided, the case will be reassessed.

• 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: 20995781
• Report Number: 0009610622-2024-00967
• Device Sequence Number: 11878176
• Product Code: LXH
• UDI-Device Identifier: 04546540145802
• UDI-Public: (01)04546540145802(10)K1B26F1
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 02276080
• Device Lot Number: K1B26F1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• 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