MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN SRG STRP31/2X6-200; SURGICAL STRIPS

Model Number	801457
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
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 delamination of the surgical strips ((b)(4)) during procedure.The nurse managed to retrieve all the piece that came off.However, this caused an impact in the management of the patient because it was impossible to use thin pieces (they swelled up too much once put in the saline and they split: delaminate).The event led to 15 minutes surgical delay, with no patient impact.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.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 using the unaided eye.The analyst noted that the strip was modified by cutting, which is a violation of the ifu (the ifu states to not cut or modify the size of the pattie/strip).The remainder of the strips did not show any signs of delamination.The complaint could not be verified through failure analysis.Per the complaint background, patties delaminate.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A device history record (dhr) review and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the dhr.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.Even though the complaint could not be confirmed through failure analysis investigation, the root cause of pattie delamination is being investigated under a corrective and preventive action (capa).
Event or Problem Description
N/a.

• Brand Name: CODMAN SRG STRP31/2X6-200
• Common Device Name: SURGICAL STRIPS
• 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: 14141531
• Report Number: 3014334038-2022-00075
• Device Sequence Number: 4025309
• Product Code: HBA
• UDI-Device Identifier: 10381780515135
• UDI-Public: 10381780515135
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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 Model Number: 801457
• Device Catalogue Number: 801457
• Device Lot Number: 5970011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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