MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRA FAST-FIX AB ASSEMBLY - REV CURVE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	72201495
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the surgery, t2 did not trigger.A backup device was used to complete the surgery.No delay or patient injury reported.
Additional Manufacturer Narrative
One curved ultra fast-fix ab assembly for use in treatment, has not been returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.An exact root cause cannot be determined with confidence.From the information provided, t2 would not deploy.However, factors that could have contributed to the reported event include: bending of the delivery needle.Pathological conditions in the soft tissue that would prevent secure fixation.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ULTRA FAST-FIX AB ASSEMBLY - REV CURVE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8838433
• Report Number: 1219602-2019-00886
• Device Sequence Number: 14099940
• Product Code: GAT
• UDI-Device Identifier: 03596010597236
• UDI-Public: 03596010597236
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 03/04/2024
• Device Catalogue Number: 72201495
• Device Lot Number: 50791023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1