MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	02276075
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
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 : ''the intramedullary nail was inserted more than 30 years ago and the patient had spent decades since the nail was extracted.The patient had fractured again and the medullary cavity was osteosclerotic, so reaming was started at 6.0 mm with a reamer also prepared for the humerus, although the site was the femur.At the reaming point of 7.5mm, the reamer became very hard and after reaming for a long time, the reamer broke at about 10cm in front of the tip.The tip remaining in the medullary cavity was pulled out with pliers and reamed again with a reamer for the femur.''.
Event or Problem Description
As reported : ''the intramedullary nail was inserted more than 30 years ago and the patient had spent decades since the nail was extracted.The patient had fractured again and the medullary cavity was osteosclerotic, so reaming was started at 6.0 mm with a reamer also prepared for the humerus, although the site was the femur.At the reaming point of 7.5mm, the reamer became very hard and after reaming for a long time, the reamer broke at about 10cm in front of the tip.The tip remaining in the medullary cavity was pulled out with pliers and reamed again with a reamer for the femur.''.
Additional Manufacturer Narrative
Correction - please refer to h6 component code.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: in the received reamer, the spiral side was found to be detached from the point where it is welded to the adapter.Just around that point, the spiral was also found to be slightly unwound.The same area shows severe scratches and scuff marks.The breakage point shows signs of a ductile breakage evident by plastic deformation of the edges.Moreover, the cutting edge of the reamer appeared to be slightly blunt.These signs apparently indicate towards a resistance in free movement of the drill ultimately leading to breakage due to torsional overload.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.Based on the above investigation, the root cause of the issue is deemed to be user related.There were signs of torsional overload which was applied on the reamer during use.Most likely due to an improper canal preparation, the reamer got stuck causing additional load on the adapter side.The operative technique recommends the user to ream the canal in 0.5mm increments until cortical contact is appreciated.Point to note: the reamer was found to be broken from the adapter side opposed to the tip as stated in the event description.If any further information is provided, the complaint report will be updated.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 19977743
• Report Number: 0009610622-2024-00790
• Device Sequence Number: 20978957
• Product Code: MAY
• UDI-Device Identifier: 04546540145796
• UDI-Public: (01)04546540145796(11)210113(10)K0CBE2C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 02276075
• Device Lot Number: K0CBE2C
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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: 59 YR
• Patient Sex: Male