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

Catalog Number 72202403

Device Problems Break (1069); Material Puncture/Hole (1504); Device Slipped (1584)

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

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a bankart repair, the surgeon passed the suture threw labrum and the capsule shift, he loaded the anchor with one suture as he is used to and he drilled the hole.After hammering in the anchor, he was going to lock the anchor he turned the locking wheel one time and it clicked directly.He was rotating the wheel a few more clicks because he is used to turn it a couple of more clicks.The anchor locked and the repair was great as it should be, but the metal piece from the inner plug inserter was left and broken in the anchor.No harm for the patient and the anchor locked in the patient.This is a reclaim because of the early locking in the anchor.I have informed the customer to stop turning the looking wheel after 2 clicks so he will not brake the metal inserter in the inner locking plug more in the future.

Manufacturer Narrative

One 72202397 bioraptor knotless suture anchor device was reported on.The product reported on is intended for hip applications.The procedure listed was a shoulder procedure.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available, the complaint will certainly be revisited.

• 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
• 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: 8262208
• MDR Text Key: 133715498
• Report Number: 1219602-2019-00090
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651273
• UDI-Public: 03596010651273
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202403
• Device Lot Number: 50754042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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