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

Model Number 72202403

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

During a posterior bankhart utilizing the bioraptor, knotless suture anchor, it was reported that the first knotless anchor was deployed with no problem.When the 2nd knotless anchor was inserted in the joint, the metal tip at the front of the inserter broke off, staying inside the implant, in the joint.The implant was buried too far down in the joint, and after a 45 minute delay of trying to retrieve it, the surgeon decided to leave it in.It was reported that the piece was not free floating and couldn't be removed without causing further damage to the patient.The surgeon is going to have an x-ray done every time, patient returns for a follow-up visit, to make sure the metal piece has not worked its way out of the implant.It was reported that there was adequate fixation, despite the issue.The bone quality was normal for a glenoid; good but not extremely hard or out of the ordinary.It was reported that no migration has occurred and the patient post-operative condition was fine.

Manufacturer Narrative

Based on available complaint details, the metal tip of the inserter remains deeply implanted within the implant and joint space.No radiologic xrays or post op notes have been made available for further clinical evidence.Furthermore, it is documented that the patient is "fine" immediately post op and the physician will obtain xrays with each follow-up clinic visit to determine migration status.A review of the available patient information does not suggest patient harm and no future harm is anticipated as a result of the retained pieces.One device was returned for evaluation.Only the device driver was returned.No anchors or sutures were returned for evaluation.The device was visually evaluated and the outer shaft is fully intact, however, the inner shaft is broken from the threads onward.The failure mode is confirmed and is currently being investigated for the root cause and applicable corrective action.(b)(4).

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR, SHOULDER
• 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: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4246170
• MDR Text Key: 5104165
• Report Number: 1219602-2014-00310
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2019
• Device Model Number: 72202403
• Device Catalogue Number: 72202403
• Device Lot Number: 50514424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2014
• 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: 20 YR