MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR KNOTLESS SUTURE ANCHOR, HIP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202397

Device Problems Material Disintegration (1177); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 10/17/2018

Event Type  malfunction  

Event Description

It was reported that when the anchor was inserted, it detached from inserter, breaking off a small metal part.It was suspected that it was due to the device being pushed in at an angle rather than straight.There was a significant delay greater than 30 minutes.A backup device was available to complete the procedure with no patient injuries reported.

Manufacturer Narrative

One 72202397 bioraptor knotless suture anchor returned.The complaint stated: ¿when the anchor was inserted, it detached from inserter, breaking off a small metal part.It was suspected that it was due to the device being pushed in at an angle rather than straight.Surgeon was unable to locate and remove the metal piece.¿ the anchor and suture were returned looped around the handle of the instrument.The anchor has been fractured at the proximal end and is flared out where the inserter would mate.Audible click is heard with rotation of the depth limiter cap.The inserter shows no damage until the distal tip.There the inserter tines have been bent and flared as well.The inner rotational shaft has been fractured from torque and loss of axial alignment.These conditions are consistent with excessive force applied and off axis alignment.This is also consistent with the allegation reported.Cautions: ¿to prepare the insertion site, only use the appropriate smith and nephew drill guides and drill bits intended for use with the bioraptor knotless suture anchor to ensure that the implant is properly aligned.Ensure that the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.Establish and maintain axial alignment of the suture anchor with the prepared insertion site.¿ use of excessive force during insertion can cause failure of the suture anchor or insertion device.No root cause associated with the manufacture of this device was confirmed.

Event Description

It was reported that when the anchor was inserted, it detached from inserter, breaking off a small metal part.It was suspected that it was due to the device being pushed in at an angle rather than straight.Surgeon was unable to locate and remove the metal piece.There was a significant delay greater than 30 minutes.A backup device was available to complete the procedure with no patient injuries reported.

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR, HIP
• 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 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8026498
• MDR Text Key: 125924654
• Report Number: 1219602-2018-01477
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: 03596010651280
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

2 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: 10/07/2021
• Device Catalogue Number: 72202397
• Device Lot Number: 50624574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0