MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72201995

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 05/30/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder joint dislocation repair, the osteoraptor anchor was fractured when screw-in.The broken pieces were removed from the patient using gripping forceps.The procedure was completed with a delay greater than 30 min and using a s+n backup device.No further complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: h2, h3, h6.The reported 2.9 osteoraptor, used in treatment, has been returned for evaluation.Visual assessment showed the anchor has broken free from the suture and was not returned for examination.The inserter and attached suture show no abnormalities.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the anchor during insertion.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported device lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10177248
• MDR Text Key: 195888938
• Report Number: 1219602-2020-00941
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010615565
• UDI-Public: 03596010615565
• Combination Product (y/n): N
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: 72201995
• Device Catalogue Number: 72201995
• Device Lot Number: 50755979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Date Manufacturer Received: 05/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75