MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD SURG PAT XRAY 1/2X1 1/2; SURGICAL PATTIES

Catalog Number	801404
Medical Device Problem Code	Extra Components (4067)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a pattie packaging with 13 patties in a packet of 10.The 3 extra patties had no string.No additional information was provided after several attempts.
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
N/a.
Additional Manufacturer Narrative
Additional information received: event date : 31/07/2023.Product reference: 801404 lot number: 6756705.When was it noticed? "pre-operative setup and checks".Was the patient under anesthesia? "yes".How did you finalize the procedure? "removed and isolated faulty items and all packets with same lot number".Was there any surgical delay due to this issue? "no".Was there any consequence(s) for the patient health? "no consequence error discovered prior to surgical knife to skin".
Additional Manufacturer Narrative
Patties were returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the pattie/strip unit was inspected by the failure evaluator.Per the failure evaluator, the 3 extra patties were present on the card, remaining patties present on the card were all acceptable per manufacturing specifications.The complaint could be verified through failure analysis.Root cause - per the complaint background, 13 patties in a pack of 10.The complaint was confirmed in the complaint investigation.Per the failure evaluator, the operator working on this lot had an alarm alert them to an issue with the string of the pattie feeding properly, and after correcting the string feeding issue, the count on the stack being produced when the alarm went off was not confirmed and the three extra patties made prior to the alarm made it on to the next stack of 10 being produced once the alarm was corrected.This is attributed to operator error for failure to confirm the count after an alarm.There is currently an open corrective and preventative action (capa) for the patties/strips product family related to x-ray polymer issues, string issues and incorrect count.
Event or Problem Description
N/a.

• Brand Name: SURG PAT XRAY 1/2X1 1/2
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17868218
• Report Number: 3014334038-2023-00164
• Device Sequence Number: 12635002
• Product Code: HBA
• UDI-Device Identifier: 10381780515005
• UDI-Public: 10381780515005
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2024

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 Catalogue Number: 801404
• Device Lot Number: 6756705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 01/16/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/24/2023; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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