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

Model 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	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zipcode (b)(6).
Event or Problem Description
It was reported that during surgery ultra fast fix t2 implant did not deploy.The procedure was successfully completed without significant delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: product ultra fast-fix ab assembly ¿ curved and ultra fast-fix ab assembly - rev curved devices used during treatment, were not returned for evaluation.This particular complaint was opened for an unidentified lot.This product style has no automatic mechanism or mechanical deployment.This product is controlled by the user to manually advance, position and deliberately strip the anchors off the needle.Per instructions for use: ¿a snap or click will be heard when the trigger is fully advanced, ensuring that the implant is fully seated at the end of the needle.Do not bend delivery needle.Do not use sharp instruments to manage or control the suture.It is normal to encounter resistance prior to achieving the ready position.¿ no root cause related to the manufacture of the device was confirmed.Complaint history review for three years prior indicated similar allegations for the product family reported.Device history review/batch/lot review was unattainable without a valid lot number provided.Product met specifications upon release to distribution.The report number for the two mentioned devices are: 1219602-2020-00072 and 1219602-2020-00071.

• 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: 9577994
• Report Number: 1219602-2020-00071
• Device Sequence Number: 2901909
• 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): 02/20/2020

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 Model Number: 72201495
• Device Catalogue Number: 72201495
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1