MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X3 -200; SURGICAL PATTIES

Model Number	80-1407
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
Upon completion of the surgery and while in the operating room, the cottonoid sponge 9 inch string broke off while attempting to remove it from the left nasal cavity.The missing surgical item (msi) radiologic film verified retained radiopaque foreign body in posterior left nasal cavity.The surgeon was able to remove it successfully and the patient had a stable recovery.The surgery performed was a nasal septoplasty with bilateral inferior nasal turbinate submucous resection and lateral outfracture with bilateral maxillary ethmoid, frontal and sphenoid sinus surgery.
Additional Manufacturer Narrative
Updated fields: d4, d10, g2, g4, g7, h2, h3, h4, h6, h10 udi #: (b)(4) dhr - there is no indication that the production process may have contributed to this complaint.Failure analysis - complaint sample was received with 4 additional packs of patties for the same lot.All returned patties were pull tested per internal procedure and found to be acceptable.801407 patties have a minimum pull test value of 2 lbs and an alert of 3 lbs.The lowest recorded pull test was 4.0 lbs.The root cause of what led to the invalid breaking off is undetermined and can be attributed to user error.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4) office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: SURG PAT XRAY 1/2X3 -200
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10292990
• Report Number: 1226348-2020-00436
• Device Sequence Number: 3218101
• Product Code: HBA
• UDI-Device Identifier: 20886704036545
• UDI-Public: 20886704036545
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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: 07/07/2024
• Device Model Number: 80-1407
• Device Catalogue Number: 801407
• Device Lot Number: J4221P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 07/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1