MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF AXIAL STARTER REAMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	1020-1200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Starter reamer was introduced into femur on power.Surgeon proceeded to ream to open canal for femoral component.Reamer broke off in patient femoral canal.After evaluation, surgeon had to retrieve broken piece by opening distal femur and then pushing the broken piece of the reamer down and out of the distal femur.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an accolade reamer was reported.The event was confirmed via evaluation of the returned device.Method & results -product evaluation and results: visual inspection and material analysis: the fracture occurred 125 mm from the distal tip of the reamer.Stereo microscope shows the proximal and distal fracture surfaces of the axial starter reamer.Based on macroscopic surface features observed.The approximate location of origin (o), direction of propagation (p), and final fracture (f) were determined.The macroscopic surface features observed, sparkling, rough features on the fracture surface indicate the fracture propagated in overload.The stereo microscope reveals widespread chipping, wear and surface damage on the edges of the starter reamer and damage to the distal tip of the starter reamer.-clinician review: no medical records were provided for review.-device history review: review of the device history records indicate 10 devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusion: characterisation using stereo microscopy and scanning electron microscopy confirmed fracture in overload.Surface damage was observed on the edges of the starter reamer.No manufacturing or material related defects were observed on the device surfaces examined.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ACCOLADE TMZF AXIAL STARTER REAMER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21974923
• Report Number: 0002249697-2025-00479
• Device Sequence Number: 7265059
• Product Code: LXH
• UDI-Device Identifier: 07613327207712
• UDI-Public: 07613327207712
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1020-1200
• Device Lot Number: MJN9P2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2010
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Unknown