MAUDE Adverse Event Report: TELEFLEX MEDICAL FORCE FIBER NON-ABSORBABLE SUTURE, WHITE/BLUE; SUTURE, NONABSORBABLE, SYNTHE

Model Number	IPN000883
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.Per failure mode a dimensional and functional inspection of the product involved does not apply.Due to the age of the lot number (2016), the dhr is not available at the teleflex (b)(4) site.Form f2090 "lot no., expiration and date of mfg matrix for the suture department" was verified which indicates the expiration date for the biomet force fiber 900335 product code.According to the information captured in sap manufacturing date: 03/03/2016, expiration date: 03/14/2021 are correct based on the procedure f2090.No discrepancy was found.A corrective action cannot be implemented at the time since no photographs or sample involved in the customer complaint was not sent for analysis.Neither impact to patient nor claim or incidence has been informed by the customer.Shipment dates and customer sale dates were verified, and no delays or discrepancies were found.This complaint was reported by the sap system team.Neither impact to patient nor claim or incidence has been informed by the customer.The customer complaint cannot be confirmed based only on the information provided to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the sample becomes available this investigation will be updated with the evaluation results.
Event or Problem Description
The sap system has informed us that 1 expired product has been consumed in a surgery when the product was being invoiced.The product expired on 14.03.2021 and was used in surgery on (b)(6) 2021.Neither impact to patient nor claim or incidence has been informed.

• Brand Name: FORCE FIBER NON-ABSORBABLE SUTURE, WHITE/BLUE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12547339
• Report Number: 3004365956-2021-00283
• Device Sequence Number: 1101282
• Product Code: GAT
• UDI-Device Identifier: 54026704601672
• UDI-Public: 54026704601672
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: IPN000883
• Device Catalogue Number: 900335
• Device Lot Number: 74C1600919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1