MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA RATCHET MECHANISM, FEMUR ELEVATOR; SURGICAL RETRACTOR

Catalog Number 11500

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Ratcheting mechanism of femur elevator no longer holds, has stopped working during surgery.(b)(6) customer reports the procedure being performed was an anterior total hip arthroplasty.Device failed about 5 minutes after it was hooked up to the patient.There was no harm to the patient.

Manufacturer Narrative

On 2/26/2016 integra investigation completed.Manufacture date determined to be before 2012.Method: failure analysis, device history evaluation.Results: failure analysis: complaint not confirmed.Unit received has passed all functional testing.No repairs needed at this time.Device history evaluation: a dhr review can not be performed because the returned device does not have a lot # etched on it.Conclusion: in summary the end users reason for return could not be duplicated as the device in question tested within specification.

• Brand Name: RATCHET MECHANISM, FEMUR ELEVATOR
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5323438
• MDR Text Key: 34271741
• Report Number: 2523190-2015-00149
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 59 YR