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

Catalog Number	64969056
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
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.

• Brand Name: GMRS TAPER SEPARATOR CHISEL
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20078159
• Report Number: 0002249697-2024-01175
• Device Sequence Number: 12678410
• Product Code: LXH
• UDI-Device Identifier: 07613327198461
• UDI-Public: 07613327198461
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 64969056
• Device Lot Number: TMP175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2006
• 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: Required Intervention; Hospitalization
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 82 KG