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); Device Dislodged or Dislocated (2923)

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

Event Date 08/08/2023

Event Type  malfunction  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A review of the polymer 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.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 anchor.The suture string is through the suture window and the distal tip of the anchor is fractured away.The threads of the anchor are deformed.There is biological debris on the returned items.Based on the condition of the product material found during visual inspection, additional material testing is not required.The complaint was confirmed, and the root cause was 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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

Event Description

It was reported that during a patellar dislocation surgery, an osteoraptor pulled out.Surgery resumed after a non-significant delay with a back-up device used in the originally drilled bone; therefore no voids were left in the patient´s bone whose quality was normal and health status good.No further complications were reported.

Manufacturer Narrative

H2: additional information: h6: medical device problem code.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 anchor.The suture string is through the suture window and the distal tip of the anchor is fractured away, this failure has been determined to be related to the reported event.The threads of the anchor are deformed.There is biological debris on the returned items.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.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 was 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: 18204792
• MDR Text Key: 328917818
• Report Number: 1219602-2023-02291
• Device Sequence Number: 1
• Product Code: MAI
• 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,Followup
• Report Date: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• 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: 2062833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 60 KG