MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR KNOTLESS SUTURE ANCHOR HIP; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202397
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that during a hip procedure, during the placement of the bioraptor knotless suture anchor hip once the shaft was removed from the anchor it was noticed that the internal screw that blocks the anchor did not come out.By a rx, it was noticed that the screw was inside the internal structure of the anchor.The metal piece could not be removed out from the patient.Patient health condition is stable.It is unknown how the procedure was finished or is there was any delay.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the subject device and the reported incident.An analysis of the customer provided images revealed that a piece of the inner shaft had broken off in the patient.It appeared to be retained within the anchor.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 a repeat issue.A review of risk management files found that the reported failure was documented appropriately.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 clinical investigation concluded the two x-rays provided confirm the report.The retained metal piece is not implantable; however, the metal piece is retained inside the internal structure of the secured implantable anchor, therefore, micro-motion or migration of the retained piece is unlikely.The procedure was completed with the same device with a 0-30-minute delay.Since no other complications were reported, no further clinical assessment is warranted this time.The complaint was confirmed.Factors that could have contributed to the reported event include over-rotation of the torque limiter, off-axis insertion or removal, or excessive force.No containment or corrective actions are recommended at this time.

• Brand Name: BIORAPTOR KNOTLESS SUTURE ANCHOR HIP
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11588795
• Report Number: 1219602-2021-00741
• Device Sequence Number: 4108527
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: 03596010651280
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K093428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: 02/20/2025
• Device Model Number: 72202397
• Device Catalogue Number: 72202397
• Device Lot Number: 2049680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/06/2021
• 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