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

Catalog Number 72203853

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/06/2019

Event Type  malfunction  

Event Description

It was reported that during the surgical procedure of slap repair through the use of anchor, when we were placing the second suturefix anchor of 1.7 it came with the white button that is used to release the sutures already activated, and then be anchored when trying to releasing the sutures and removing the handle one of the ends was completely loose from the anchor and when testing the tension the other was released.So a new anchor had to be placed.The procedure was completed with a back up device with no patient injuries or delay.An additional bone hole was required.

Manufacturer Narrative

One 72203853 suturefix ultra anchor device reported on.The product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not attainable without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1)use of other that recommended smith and nephew drill and proper size and spade style drill bit ensuring proper depth.2) the primary cutting edges of the drill are not sharp or have dings and burrs.3) stressed product from loss of axial alignment.4) inadvertent rotation of device during seating of anchor.5) unexpected bone density/condition.

Manufacturer Narrative

One suturefix ultra suture anchor device returned.The complaint stated: ¿it came with the white button that is used to release the sutures already activated, and then be anchored when trying to releasing the sutures and removing the handle one of the ends was completely loose from the anchor and when testing the tension the other was released.¿ the handle body, button, trigger and suture cover are all intact and appear undamaged.The inserter was returned.There is no damage and the fork tines are intact.The deployment sleeve was deployed and locked.Two severed sections of suture and tainted textile anchor were loosely looped around the product handle.The anchor was damaged; extremely frayed and abraded.Following instructions for use, recommended prep is essential for successful anchoring and repair and includes precautions for successful fixation.¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Smith and nephew suturefix anchors are intended for the reattachment of soft tissue to bone.Breakage of the suture anchor can occur if the insertion site is not prepared with appropriate instrumentation prior to implantation.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.Do not use sharp instruments to manage or control the suture.Implantation of the suture anchor requires preparation of the insertion site.¿ preferred method of site prep is predrilling with the appropriate smith and nephew drill bit.Recommendation is a same size drill bit as the anchor.The depth is critical for proper anchor seating.¿once seated do not rotate the suture anchor device in the bone as this may cause device failure.Pull back slowly on the handle to remove insertion device.The anchor will remain in the bone¿.Root cause related to manufacturing was not confirmed.

• Brand Name: SUTUREFIX ULTRA AHR S 2 UB STR CB BLU
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8370899
• MDR Text Key: 137537126
• Report Number: 1219602-2019-00242
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 00885554031447
• UDI-Public: 00885554031447
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Catalogue Number: 72203853
• Device Lot Number: 50698048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 03/25/2019; 05/08/2019
• Supplement Dates FDA Received: 03/26/2019; 05/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 77