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

Model Number	801404
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was not returned for evaluation; however, a photo was provided and analyzed.Dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - complaint confirmed, 11 patties presented in the photo.The complaint could be verified through failure analysis.Root cause - the complaint was confirmed in the complaint investigation.Per the failure analyst: ¿801404 patties are produced using hybrid equipment which uses and operator to cycle the machine and inspect the patties.The machine produces 10 patties and stacks them for the operator to review.It appears the machine was cycled once and stopped at the first pattie.When the operator reset the machine they did not clear out the patties made then produced a stack on 10 on top of the initial 1.This resulted in 11 patties present.The operator did not properly inspect the stack of 10 for proper count.An operator retraining will be completed to address the issue.¿ a corrective action was implemented to further investigate the issue.
Event or Problem Description
A facility reported there were 11 surgical patties in the packet instead of 10.No patient injury reported.It is unknown if the event led to surgical delay.

• 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
• MDR Report Key: 12662317
• Report Number: 3014334038-2021-00214
• Device Sequence Number: 1179430
• Product Code: HBA
• UDI-Device Identifier: 10381780515005
• UDI-Public: 10381780515005
• 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
• Report Date (Section B): 10/19/2021

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: 06/30/2026
• Device Model Number: 801404
• Device Catalogue Number: 801404
• Device Lot Number: 5542810
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1