MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE CV5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	P5K17A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to gore that when a gore-tex® suture was used to suture a lesion in the patient¿s mouth, a needle bent was experienced at the first needle puncture.It was stated that therefore a second gore-tex® suture was used where it was reported that a needle pull off occurred during the procedure.The occurrences did not require a reintervention and no fragments remained in the patient¿s mouth.
Additional Manufacturer Narrative
The review of the manufacturing records verified that this lot met all pre-release specifications.Our engineers have evaluated the returned device.Their investigation concluded that the state of the returned device is consistent with the reported complaint of needle separation.The needle does not appear to exhibit any signs of instrument damage.There appears to be a small remnant of fiber visible inside the needle bore, typical in reports of needle pull off, and evidence of a formerly secure attachment.100% of attachments undergo an in process test at needle attach to ensure that every attachment meets tensile strength requirements.Additionally, each lot is sampled and qc tested for needle attach tensile strength and must meet the release requirements to be dispositioned as accept.The suture hazards analysis, and process fmea address the failure modes and hazardous situations resulting from needle separations.Based on the information available, the root cause is not able to be determined.

• Brand Name: GORE-TEX® SUTURE CV5
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8442911
• Report Number: 3003910212-2019-00047
• Device Sequence Number: 19597445
• Product Code: GAW
• UDI-Device Identifier: 00733132607624
• UDI-Public: 00733132607624
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: 06/30/2023
• Device Catalogue Number: P5K17A
• Device Lot Number: 18589843A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1