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

Catalog Number 72202403

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an arthroscopy bankarts repair, after the anchor was deployed into the pilot hole, while sutures were cut, the anchor came out.An additional hole was drilled.A backup device was available to complete the procedure with no significant delay or patient injuries reported.

Manufacturer Narrative

: one 72202403 bioraptor knotless suture anchor device used for treatment, was returned for evaluation.The complaint stated: ¿after the anchor was deployed into the pilot hole, while sutures were cut, the anchor came out.¿ the anchor and cut segment of suture were returned attached to the inserter.It was slightly flared at the proximal end.The grub was fully forwarded.The torque limiter was tested.Audible click was present upon rotation.The inner rotational rod advanced as expected.There was no damage noted.¿it is the responsibility of the surgeon to determine the patient¿s bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.The torque limiter, located at the proximal end of the insertion device handle, is preset and should not be turned until the anchor has been fully seated and proper tension has been applied to the suture.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.Breakage of the suture anchor can occur if the insertion site is not prepared with the recommended smith and nephew drill prior to implantation.¿ a 72201395 (spade drill bit) is recommended for the reported procedure.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

Manufacturer Narrative

One 72202403 bioraptor knotless suture anchor device used for treatment, was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available, the complaint will certainly be revisited.Product met specifications upon release to distribution.

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8810167
• MDR Text Key: 151716319
• Report Number: 1219602-2019-00843
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651273
• UDI-Public: 03596010651273
• Combination Product (y/n): N
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Catalogue Number: 72202403
• Device Lot Number: 50606086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Date Manufacturer Received: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1