MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72201992
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an unknown procedure, during the insertion of the anchor, it was bent and broken.Procedure was successfully completed with the same device.No significant delay and no patient complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the anchor had been deployed from the device.The device inserter was slightly bent at the distal end.The anchor was returned with a severe bend at the eyelet and deformation on the surrounding threads.There was significant debris on the anchor.The suture had not been removed.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: breakage of the suture anchor can occur if the insertion site is not prepare with the recommended drill prior to implantation.Ensure the anchor placement is aligned with the drilled hole.Proper alignment is essential for successful repair.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.A clinical investigation concluded that based on the limited information the patient impact beyond local irritation/discomfort, and/or migration, tissue inflammation and/or pain cannot be determined.The anchor is implantable, so biocompatibility is not an issue.No further clinical/medical assessment is warranted at this time.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, off-axis insertion, or improper preparation of the insertion site.

• Brand Name: OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11091647
• Report Number: 1219602-2020-02188
• Device Sequence Number: 2712632
• Product Code: MAI
• UDI-Device Identifier: 03596010615534
• UDI-Public: 03596010615534
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2024
• Device Model Number: 72201992
• Device Catalogue Number: 72201992
• Device Lot Number: 2033493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention