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); Mechanical Jam (2983); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "tip stuck in medullary cavity during reaming and damaged when trying to turn with handpiece".
Additional Manufacturer Narrative
The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned reamer was confirmed based on the catalog # and the lot # marked.The instrument is broken in two parts, both parts have been returned.The breakage occurred at the beginning of the shaft, close to the end where the assembly with the t-handle is performed.The portion of the shaft close to the breakage is highly twisted and worn out, with multiple scratches on its surface.The deformation observed gives indication that the instrument broke in a ductile way.The fracture most probably was generated and developed due to an increased repetitive torsional stress, ultimately leading to a final/ catastrophic breakage.It must be noted, that the reaming tip of the instrument, although having signs of use, does not show any particular sign of major damage.Dimensional inspection has confirmed that the device was manufactured according to the specifications.Based on investigation, the root cause was attributed to an user related issue.Given that the fracture occurred at the beginning of the shaft, it could be concluded that the breakage was caused by excessive torsional being applied to the reamer, most probably using a power tool.The lack of substantial damage on the tip indicates that there was most probably no hard bone and that the root cause of breakage is solely hcp related.Nonetheless, without x-rays, the presence of hard bone could not be fully excluded.The damage of the teflon tube (concomitant) could indicate the use of a wire, although the presence or not of a k-wire is impossible to confirm.As a reminder, the absence of a k-wire can cause an uncontrolled drift of the reamer, which could help causing the breakage.As stated by the instructions for use: always perform intramedullary reaming over a k-wire to prevent the reamer from drifting uncontrollably.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.
Event or Problem Description
As reported: "tip stuck in medullary cavity during reaming and damaged when trying to turn with handpiece".

• 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: 20412353
• Report Number: 0009610622-2024-00859
• Device Sequence Number: 8222055
• Product Code: LXH
• UDI-Device Identifier: 04546540145802
• UDI-Public: (01)04546540145802(10)K125B0F
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/26/2024

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: 02276080
• Device Lot Number: K125B0F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2023
• 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: 17 YR
• Patient Sex: Male