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 Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Perforation (2001)

Event Date 03/08/2024

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, during a shoulder joint surgery, when the osteoraptor anchor was implanted, it pulled out and was deformed.The anchor was removed directly.Surgery was completed with a back-up device in an additionally drilled bone hole, a void was left in the patient.There was a surgical delay greater than 30 minutes, and no further complications were reported.

Manufacturer Narrative

H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The insertion device was returned with the suture string and a fractured anchor loose on the shaft.The device is encrusted with biological debris.The proximal end of the anchor has a section fractured away that was not returned.Based on the condition of the product material found during visual inspection, additional material testing is not required.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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 anchor 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 reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• 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: 18989944
• MDR Text Key: 338743578
• Report Number: 1219602-2024-00644
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201995
• Device Lot Number: 2125834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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 Outcome(s): Required Intervention