MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS TAPER SEPARATOR BODY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	64969054
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Disconnect (2541)
Health Effect - Clinical Codes	Ambulation or Postural Difficulties (2544); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Was trying to separate a gmrs stem from a gmrs distal femoral growing prosthesis.The taper separator failed to release the taper.Surgeon was unable to complete the lengthening of the patients femur.Delayed the surgery over 1 hour while surgeon tried to disassociate the components.Future surgery will be required.
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
Was trying to separate a gmrs stem from a gmrs distal femoral growing prosthesis.The taper separator failed to release the taper.Surgeon was unable to complete the lengthening of the patients femur.Delayed the surgery over 1 hour while surgeon tried to disassociate the components.Future surgery will be required.
Additional Manufacturer Narrative
An event regarding disassembly issue involving a gmrs separator was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: inspection of the returned device indicated that the chisel had fracture off from the taper separator body in overload.Clinician review: no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicate 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: it was reported that the patient was revised due to failure to disassemble.Inspection of the returned device indicated that the device was had fracture off from the taper separator body in overload.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: GMRS TAPER SEPARATOR BODY
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20078203
• Report Number: 0002249697-2024-01174
• Device Sequence Number: 18032800
• Product Code: LXH
• UDI-Device Identifier: 07613327198430
• UDI-Public: 07613327198430
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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 Expiration Date: 03/31/2011
• Device Catalogue Number: 64969054
• Device Lot Number: TMP124A
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2006
• 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: Hospitalization; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 82 KG