MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W. UB COBRAID BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72201993

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an anterior talofibular ligament of the right ankle surgery, the osteoraptor anchor broke.The procedure was completed with non-significant surgical delay using a back-up device in the originally drilled bone hole and no void was left in the patient and all the broken pieces were removed from the patient.The insertion site was cleared of all debris prior to insertion of the anchor.No further complications were reported.Current status of patient is fine.

Manufacturer Narrative

A device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: OSTEORAPTOR 2.3 W. UB COBRAID BLUE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19214363
• MDR Text Key: 341405585
• Report Number: 1219602-2024-00903
• Device Sequence Number: 1
• Product Code: MAI
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201993
• Device Lot Number: 2089364
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2024
• Date Device Manufactured: 04/21/2022
• 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: 24 YR
• Patient Sex: Female