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

Model Number 72202397

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Event Description

It was reported that, during an arthroscopy, while inserting the bioraptor a small fragment from the inserter remained inside the anchor.The metal fragment was removed using graspers.An additional anchor was placed to ensure proper fixation.There was a backup device available.No significant delay or further complications were reported.

Manufacturer Narrative

One 72202397 bioraptor knotless suture anchor device, used in treatment, was not returned for evaluation.Evaluation was limited without product available.Instructions for use (ifu) contains recommendations and precautionary statements for proper use of product.Influences unrelated to manufacture that could compromise product performance or integrity include: difficulty with establishing and maintaining axial alignment of suture anchor with prepared insertion site.Excess force placed upon the product.Per ifu 10600479: ¿breakage of the suture anchor can occur if the insertion site is not prepared with the recommended smith and nephew drill prior to implantation.Warning: 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.Caution: ensure that the anchor placement is aligned with the drilled hole.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.¿ complaint history review indicated a similar allegation for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Risk management files contain the reported failure.Various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.No indications from the device show cause that the material was related to the reported failure.Product met specifications upon release to distribution.Post market surveillance activities will continue to monitor this failure mode.No additional actions required at this time.

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR HIP
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10293079
• MDR Text Key: 199450288
• Report Number: 1219602-2020-01081
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: 03596010651280
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202397
• Device Catalogue Number: 72202397
• Device Lot Number: 2034461
• Date Manufacturer Received: 08/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention