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

Catalog Number 72201995

Device Problems Fracture (1260); Insufficient Information (3190)

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

Event Date 05/23/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection revealed that the returned device was not in its original packaging.The insertion device was returned with the anchor and suture strings off the device.There was debris on the returned items.The suture strings were no longer through the suture window of the anchor.The proximal end of the anchor was fractured and deformed.A full functional evaluation could not be performed because the anchor was damaged and the suture string was no longer in the channel of the device.The sliding ring functioned as designed.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include an application of improper/excessive force.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during an arthroscopy procedure, the osteoraptor anchor was found slipped and could not screw-in.The procedure was successfully completed using a back-up device, it is unknown if there was a surgical delay due to the reported event.No further complications were reported.Results of investigation revealed that the proximal end of the anchor is fractured and deformed.Per the results of the investigation, the visual inspection showed the proximal end of the anchor is fractured and deformed.

• 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
• 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: 18445940
• MDR Text Key: 331925915
• Report Number: 1219602-2024-00032
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010615565
• UDI-Public: 03596010615565
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201995
• Device Lot Number: 2062823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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