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

Catalog Number 64969056

Device Problem Insufficient Information (3190)

Patient Problem Ambulation Difficulties (2544)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It was reported that, for a patient who was operated several times by the same surgeon, the last surgery was the second failed attempt to exchange the growing piece of his gmrs implant (hmrs/gmrs spigot separator).A longer growing piece is needed, growing piece the patient currently has failed/lost it¿s ability to keep it¿s full length.It is suspected that separation of the stem/growing piece spigot failed because of cold fusion.The patient ((b)(6) boy) has 6cm difference in leg length, the original growing component is set to it¿s maximum length but as it¿s collapsed once the patient¿s parents lost their trust in the device.It is not clear why/how the device lost it¿s internal blockage, but the surgeon found it collapsed (in the shortest position instead of the last set elongation) in the operation when they wanted to do the last adjustment ( the last 5mm ) before changing to the longer piece.After they went through the elongation steps again - 2-3 small surgeries - they reached full length again, the device showed no signs of failure/instability.

• Brand Name: GMRS TAPER SEPARATOR CHISEL
• Type of Device: 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
• Manufacturer Contact: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8214936
• MDR Text Key: 132042818
• Report Number: 0002249697-2019-00035
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327198461
• UDI-Public: 07613327198461
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 64969056
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other