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

Catalog Number 72202403

Device Problems Device Slipped (1584); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 02/12/2013

Event Type  Injury  

Event Description

During a procedure, it was reported that the metal part that runs down the anchor is loose and they managed to remove the part with a handheld instrument.The loose part was discarded in error.There was no reported harm to the patient.The anchor the locking plug is left stuck in the inserter but the anchor has been released.It was reported that the metal inserter was not left inside the anchor, but the anchor part is left in the patient but not the inner plug which was stuck on the inserter.The surgeon drilled a new hole to insert a new anchor beside the broken inner- plug- anchor.The surgeon got an adequate fixation, but there was needed an extra anchor in the joint because they could not do any fixation from that anchor because of the missing inner plug.The procedure was completed with no patient harm reported.There was an unspecified delay in completing the procedure.

Manufacturer Narrative

(b)(6).Three devices were returned for evaluation.The device was confirmed to have the inner shaft broken at the distal tip.The device has the inner plug stuck on the distal tip of the inner shaft.The device was disassembled at the back end and the inner shaft has been unscrewed out of the outer.Per the ifu, the knob is only supposed to be unscrewed about a quarter turn after insertion just to facilitate removal of the anchor.It appears that at some point during use, the knob was rotated counterclockwise several times causing the inner shaft to disengage.(b)(4).

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4947109
• MDR Text Key: 6193527
• Report Number: 1219602-2015-00552
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/16/2015

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: 10/31/2017
• Device Catalogue Number: 72202403
• Device Lot Number: 50438329
• Other Device ID Number: 240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2013
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2012
• 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 Outcome(s): Required Intervention