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

Catalog Number 11500

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the femur ratchet mechanism (prod id 11500) fractured into multiple pieces during an anterior hip replacement on.It broke when the retractor was extended and pressure was put on the part.They then went to manual retraction to complete the procedure, and there was no adverse consequence to the patient or surgical delay.It was also reported that the product was sterilized and kept in an appropriate location for sterile supplies before it was used.

Manufacturer Narrative

The femur elevator (11500) was not returned and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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
• MDR Report Key: 11303111
• MDR Text Key: 241010486
• Report Number: 2125289-2021-00001
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1