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

Catalog Number 72201993

Device Problems Break (1069); Device Fell (4014)

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

Event Date 10/11/2018

Event Type  malfunction  

Event Description

It was reported that during glenoid labrum repair surgery,while implanting, the anchor fell off the suture.Back up was used to complete the procedure.The anchor broke inside the patient, however, all the pieces were removed.No patient or significant delay were reported.Back up was used to complete the procedure.

Manufacturer Narrative

One 2.3 osteoraptor inserter and two legs of ultrabraid suture were returned for evaluation.Anchor was not returned.The 2.3 osteoraptor in this configuration is supplied with one leg of suture 38 inches in length.Visual assessment of the inserter showed no abnormalities.The suture is free from the inserter.One leg of the suture has been cut approximately mid-point of its length and is missing approximately two inches of its total length; this suture appears to be from a successfully implanted device.The additional leg of suture is intact and shows no abnormalities.Without the return of the anchor no root cause can be determined.

• 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: 8038055
• MDR Text Key: 126516779
• Report Number: 1219602-2018-01497
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010615541
• UDI-Public: 03596010615541
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Catalogue Number: 72201993
• Device Lot Number: 50696108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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: 67 YR
• Patient Weight: 68