MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX ULTRA AHR S W/2 UB STR 1 BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72203854

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that when the sururefix was being used, the anchor did not hold and it frayed.The damaged device was extracted and the problem was solved using a back up device.No delay or further complication was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3,h6: one 72203854 suturefix ultra anchor suture anchor used for treatment, was not returned for evaluation.Due to product unavailability evaluation was limited.If further information becomes available the complaint can be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Influences unrelated to manufacture that could compromise product performance or integrity include: 1) inadvertent rotation of device during anchor seating.2) use of other than recommended smith and nephew drill and proper size and spade style drill bit ensuring proper depth.3) unexpected bone density/condition.4) the primary cutting edges of the drill were not sharp, had dings or burrs.5) product stressed from loss of axial alignment.Ifu contains several precautions that can affect successful fixation.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.Allegation rate of occurrences continue to be monitored via surveillance.Relationship between the event and device was not confirmed.Per clinical/mi: no relevant clinical information is provided, recommend closure.

• Brand Name: SUTUREFIX ULTRA AHR S W/2 UB STR 1 BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10477755
• MDR Text Key: 205139546
• Report Number: 1219602-2020-01339
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554030044
• UDI-Public: 00885554030044
• Combination Product (y/n): N
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203854
• Device Catalogue Number: 72203854
• Device Lot Number: 2034822
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention