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

Catalog Number	TG451
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem Description
N/a.

• Brand Name: TENOGLIDE TENDON PROTECTOR SHEET 4IN X 5IN (10CM
• Common Device Name: 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
• Report Number: 1121308-2023-00032
• Device Sequence Number: 12399968
• Product Code: FTM
• UDI-Device Identifier: 10381780032458
• UDI-Public: 10381780032458
• Combination Product (Y/N): N
• PMA/510(K) Number: K053655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 09/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown