MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR KNOTTLESS; BIORAPTOR, KNOTLESS SUTURE ANCHOR

Model Number 72202403

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584)

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

Event Date 09/03/2014

Event Type  malfunction  

Manufacturer Narrative

The customer confirmed that the bone site was predrilled with a 2.7mm awl and that the initial site was left empty.Although the device was marked as available and several attempts made requesting the return, to date the device has not been received by the manufacturer.(b)(4).

Manufacturer Narrative

Device evaluation: one bioraptor knotless suture anchor was returned for evaluation.Visual assessment of the device shows the anchor is misaligned on the inserter shaft and cannot be removed confirming the complaint.Review of the assembly process and component drawings confirmed this failure mode is highly detectable due to the manual nature of the assembly process and the geometry of the mating components.It appears that during insertion of the anchor, the inserter became disengaged and upon reengagement, alignment was not properly maintained causing the anchor to become wedged on the inserter resulting in the non-deployment.A review of the device history records confirmed that no abnormalities were reported with this product lot during manufacture.Due to these observations no root cause related to the manufacturing process can be established.No further investigation is warranted at this time.(b)(4).

Event Description

During an unknown procedure using a bioraptor, knotless suture anchor, it was reported that the anchor came loose and did not hold the cortex.The anchor was removed and surgery was completed with an available back-up device.It is unknown if the surgeon placed the second device in the initial prepared site or left the site empty.There were no reports of patient injuries or complications.

Manufacturer Narrative

The device was marked as available for evaluation in section d10; although anticipated, the device has not yet been received.(b)(4).

• Brand Name: BIORAPTOR KNOTTLESS
• Type of Device: BIORAPTOR, KNOTLESS SUTURE ANCHOR
• 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: brenda driscoll ; 150 minuteman road; andover, MA 01810 ; 9787491462
• MDR Report Key: 4124220
• MDR Text Key: 12532424
• Report Number: 1219602-2014-00285
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 72202403
• Device Catalogue Number: 72202403
• Device Lot Number: 50433337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/07/2014; 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2012
• 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