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

Model Number 72202397

Device Problem Bent (1059)

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

Event Date 03/23/2018

Event Type  malfunction  

Event Description

It was reported that the anchor bent inside the arthroscope.No significant delay or patient injury reported.

Manufacturer Narrative

Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

Manufacturer Narrative

One bioraptor knotless suture hip anchor was returned for evaluation.Visual assessment of the device shows it is complete.The anchor tip is bent and the inner grub screw has been advanced out of the proximal end of the anchor.The torque limiter was functionally tested and found to perform as intended.The damage to the anchor indicates the inner plug was advanced excessively counter clockwise during use.

• 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: 7463233
• MDR Text Key: 106625563
• Report Number: 1219602-2018-00492
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: (01)03596010651280(17)220516(10)50664571
• Combination Product (y/n): N
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2022
• Device Model Number: 72202397
• Device Catalogue Number: 72202397
• Device Lot Number: 50664571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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
• Patient Age: 83 YR