MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W. UB COBRAID BLUE; STAPLE, FIXATION, BONE

Model Number 72201993

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 08/13/2018

Event Type  malfunction  

Event Description

It was reported that during the glenoid labrum repair surgery, the anchor of osteoraptor broke.All the pieces were removed from the patient.No patient injury or significant delay was reported.Procedure was completed with a back up device.

Manufacturer Narrative

One 72201993 osteoraptor 2.3mm suture anchor returned.The complaint stated: "it was reported that during a glenoid labrum repair surgery, the anchor of osteoraptor broke." the insertion shaft device, suture and partial anchor were returned.There is no damage, bow or bending of the insertion shaft.The ultrabraid suture was returned attached to the handle.The anchor was attached to suture through the eyelet but no longer attached to the distal tip of the inserter.There are proximal barbs missing.Material missing where it attaches to the inserter.The anchor has been fractured at the location where the inserter seats inside the anchor.This condition is consistent with force and potentially losing axial alignment.A starter instrument is mandatory for this device's prep.This product recommends and specified drill bit, a 2.3mm in line drill and a 2.3mm obturator.These are purchased separately.No root cause related to the manufacturing of this device was established.

• Brand Name: OSTEORAPTOR 2.3 W. UB COBRAID BLUE
• Type of Device: STAPLE, FIXATION, BONE
• 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 ; 5123585706
• MDR Report Key: 7847103
• MDR Text Key: 119501347
• Report Number: 1219602-2018-01185
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010615541
• UDI-Public: (01)03596010615541(17)210823(10)50617288
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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: 08/23/2021
• Device Model Number: 72201993
• Device Catalogue Number: 72201993
• Device Lot Number: 50617288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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: 64 YR
• Patient Weight: 68