MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRATAPE 2MM BLUE 38 PKG OF 6; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	72203896
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an acl reconstruction procedure, when linking the acl graft and suture button, the ultratape suture broke.The suture was removed from the body.A back-up device was available to complete the procedure with extended surgical time of 15 min.The patient was not injured.
Additional Manufacturer Narrative
One and a half strands of ultra tape were returned (previously reported to the fda; refer to 1219602-2019-00499).One elite premium knot manipulator was returned.These two complaints share an attached investigation.The complaints relayed that ¿during an acl reconstruction procedure, when knotting, the knot manipulator cut the ultratape suture.¿ the knot manipulator is a two year old reusable instrument.It was found in good condition.There is no obvious damage.The shaft is straight.There are no sharp edges on the distal tip configuration.The ultratape returned with one entire strand and a second partial strand.It had a severed end.In proximity there were also snags and scuffed fibers noted.This is consistent with being run back and forth through the manipulator or snagging on a separate instrument or device.During evaluation the entire tape strand was repeatedly run back and forth through the manipulator.Tension was applied.There was no ill effect.Customer's video clip showed the knot manipulator tensioning the knots.At 00:47 there is evidence that the tape had already been damaged.Already existing thin and torn fibers were noted.At that point, the compromised tape was barely holding the last two knots together.With cinching and retrieval of the manipulator the final knot broke free; pulling back up with the loop.There are no other instances reported for this lot.At this time, this is considered an isolated occurrence.Correction in g3: company representative should not be marked.
Additional Manufacturer Narrative
Additional information was identified by the manufacturer requiring this event to be re-evaluated for fda reporting.The result of a second review of the reported event, the available information and the sequence of steps related to the acl reconstruction revealed that the suture breakage, when placing the linkage of the graft and the button inside of the knee, will not cause or contribute to a serious injury or death as this breakage can be solved by the physician by replacing the suture with no damage to body structures.This event resulted in a non-significant delay and the surgery was successfully completed with a replacement device with no harm to the patient.Mdrs 1219602-2019-00477 and 1219602-2019-00499 were originally submitted for this event.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.These reports were made based upon information that smith & nephew had not been able to verify before.

• Brand Name: ULTRATAPE 2MM BLUE 38 PKG OF 6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8561137
• Report Number: 1219602-2019-00477
• Device Sequence Number: 2293388
• Product Code: GAT
• UDI-Device Identifier: 00885554031638
• UDI-Public: 00885554031638
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2019

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: 09/04/2023
• Device Catalogue Number: 72203896
• Device Lot Number: 50756665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/02/2019; 05/15/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/03/2019; 05/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1