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 Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the 4 limbs of the suture were found detached from the anchor and cane out loose.The doctor decided to use a 1.7mm suturefix instead.And 3 anchors were used uneventfully.There a delay shorter than 30 minutes and no further complication were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h2, h3, h6: one 72203854 suturefix ultra suture anchor device used in treatment, was returned for evaluation.No anchor was returned.The inserter device; handle body, button, trigger cover were returned.Cobraids were returned without the textile anchor attached.They were torn and frayed at the anchor location.The trigger was found partially locked indicating an incomplete insertion.The anchor was not fully deployed.Once fully deployed, the white locking button cannot be removed.The distal tip of the outer tube tip was unusually flared and scuffed.It indicated contact with another device or instrument.Inspection of the inner shaft confirmed that the fork tines were intact and undamaged.Following instructions for use recommended prep is essential for successful use.Instructions for use highlights several precautions that can affect successful fixation.Smith and nephew suturefix anchors are intended for the reattachment of soft tissue to bone.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Only use the recommended drill bits and drill guides intended for use with the suturefix ultra suture anchor.Use of other instruments may injure the patient, damage the instruments, or compromise fixation.Once seated do not rotate the suture anchor device in the bone as this may cause device failure.Incomplete anchor insertion may result in poor anchor performance.Pull back slowly on the handle to remove insertion device.The anchor will remain in the bone.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.No root cause related to the manufacture of this device was confirmed.Product met specifications upon release to distribution.

• 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: 10425966
• MDR Text Key: 203512639
• Report Number: 1219602-2020-01276
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2024
• Device Model Number: 72203854
• Device Catalogue Number: 72203854
• Device Lot Number: 2035456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention