MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 2MM HEX SCREWDRIVER FOR DISTAL FEMORAL GROWING PROSTHESIS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 6497-2-300

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem Ambulation Difficulties (2544)

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that surgeon was performing a limb-lengthening on the gmrs knee system in patient's right knee.Rep reported there were issues with the smaller 2mm locking screwdriver to unlock the prosthesis.Surgeon attempted to turn the bigger knob to lengthen the patient's leg - the knob turned 1 full turn and locked.As reported by rep: "the locking knob wasn't biting with the driver." the surgeon returned the prosthesis to the baseline state and ended the procedure.Rep reported that the patient will suffer a leg length discrepancy until a solution can be found.The screwdrivers are available for return to stryker, the prosthesis remains implanted in the patient.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

An event regarding damage involving an gmrs other instrument was reported.The event was confirmed.Device evaluation and results: visual inspection showed the tip of the screwdriver was damaged.Material analysis of returned device was performed and indicated that in-service use damage observed on the tip of the device.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed but root cause could not be determined because the insufficient information was provided.On the basis of visual inspection and martial analysis engineer as indicated that in-service use damage observed on the tip of the device.Further information such as pre- and post-op xrays, patient history, histopathology report & follow-up notes are needed to investigate this event further.If the additional information are received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that surgeon was performing a limb-lengthening on the gmrs knee system in patient's right knee.Rep reported there were issues with the smaller 2mm locking screwdriver to unlock the prosthesis.Surgeon attempted to turn the bigger knob to lengthen the patient's leg - the knob turned 1 full turn and locked.As reported by rep: "the locking knob wasn't biting with the driver." the surgeon returned the prosthesis to the baseline state and ended the procedure.Rep reported that the patient will suffer a leg length discrepancy until a solution can be found.The screwdrivers are available for return to stryker, the prosthesis remains implanted in the patient.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: 2MM HEX SCREWDRIVER FOR DISTAL FEMORAL GROWING PROSTHESIS
• Type of Device: 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6973944
• MDR Text Key: 90759383
• Report Number: 0002249697-2017-03095
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6497-2-300
• Device Lot Number: TABTD00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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
• Patient Age: 12 YR