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

Model Number 72202397

Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597)

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

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's zip code: (b)(6).

Event Description

It was reported when removing the inserter handle, first the orange handle came off and completely detached from the metal shaft, and then when the surgeon removed the metal shaft, an approx 15mm long piece of the distal tip of the inserter snapped off and was stuck in the anchor.The surgeon eventually managed to remove it from the anchor but it then floated off round the back of the femoral head.The surgeon had to make a posterior portal to be able to access this area, but could not grasp it with an arthroscopic grasper.Eventually he used a curved shaver blade to suck the piece into the blade and thus remove it from the joint.No patient injury reported.

Manufacturer Narrative

Device investigation narrative - one bioraptor knotless suture anchor assembly was returned for evaluation.Only the inserter was returned.The device was returned with the shaft within the handle.The shaft could easily be removed.Dimensional assessment of the knurl confirmed it met print specification.Examination of the handles cavity showed multiple sinks it also showed no witness marks for purchase of the shaft knurl in the first half of the cavity.The inner shaft tip has broken off.Examination of the tip shows it has been twisted at the break area to failure.Device was evaluated by quality engineering and was found to be dimensionally within print specifications.It appears that the shaft coming free from the handle contributed to the breakage of the inner shaft.A review of the complaint records confirmed this failure mode to be isolated in nature.No additional actions are warranted at this time.Device returned for evaluation device evaluated by the manufacturer evaluation codes updated c-(b)(4).

• 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
• MDR Report Key: 6999557
• MDR Text Key: 91353321
• Report Number: 1219602-2017-01363
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: (01)03596010651280(17)220124(10)50643624
• 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: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 72202397
• Device Catalogue Number: 72202397
• Device Lot Number: 50643624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• 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