MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 1/2X1/2-200; SURGICAL PATTIES

Catalog Number	801400
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2023
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 a surgical patty (id (b)(4) ) detached from the string while in patient.The patties were moistened 30 minutes prior to use, irrigated during use and the product was not altered or cut from the original size prior to use.There was a 30-minute surgical delay due to search for missing patty and needing to obtain x-ray to rule out being in patient.Surgeries being performed were c3-c7 decompressive laminectomies and c2-t1 posterior cervical fusion with depuy symphony.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h4, h10.The surgical patty (id 801400) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h6, h11 the surgical patty (id 801400) was not returned for evaluation, but a photo was provided showing the green string detached.Therefore, the complaint is confirmed.Root cause - potential root causes include insufficient string strength, material thickness variation, environmental conditions, improper welding parameters, or user misuse.There is currently an open corrective and preventative action (capa) for the patties/strips product family related to string issues.

• Brand Name: SURG PATXRAY 1/2X1/2-200
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 17483732
• Report Number: 3014334038-2023-00131
• Device Sequence Number: 21053984
• Product Code: HBA
• UDI-Device Identifier: 10381780514961
• UDI-Public: 10381780514961
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2024

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: 801400
• Device Lot Number: 6560987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 05/02/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/29/2023; 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2022
• 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