MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP TENOGLIDE TENDON PROTECTOR SHEET 4IN X 5IN (10CM; N/A

Catalog Number TG451

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported an expired tenoglide tendon protector sheet (id tg451) was implanted.The operative room staff pulled an implant from the file cabinet that was expired, and it was implanted before staff noticed.The surgeon made aware after implanting and decision was made to not explant the tg.No patient injury reported.

Manufacturer Narrative

The tenoglide (id tg451) was not returned for evaluation (remains implanted), therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue 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: TENOGLIDE TENDON PROTECTOR SHEET 4IN X 5IN (10CM
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORP; 1100 campus drive; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17780417
• MDR Text Key: 323826458
• Report Number: 1121308-2023-00032
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10381780032458
• UDI-Public: 10381780032458
• Combination Product (y/n): N
• PMA/PMN Number: K053655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: TG451
• Device Lot Number: 5329401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1