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	05/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the iron pieces of the bioraptor anchor broke while loading and trying to retrieve the device.The broken pieces were retrieved from the patient by using a grasper.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.
Event or Problem Description
It was reported that during an arthroscopy using the bioraptor, metal pieces of the anchor inserter broke off after loading upon removal from the patient.The broken pieces were retrieved using a grasper.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.Complaint 1 of 2.Reference (b)(4) (mdr 1219602-2021-01318) for related complaint.
Additional Manufacturer Narrative
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 returned device and the reported incident.An analysis of the customer provided image shows a twisted inserter tine with metal debris in the arthroscopic view.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 complaint history review for the reported batch number concluded this was an isolated event.The instructions for use was 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 review of risk management files found that the reported failure was documented appropriately.A review of the polymer specifications found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.The complaint was confirmed.Factors that could have contributed to the reported event include an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device did not contribute to the reported event.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 an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an 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.A review of the customer provided image found an arthroscopic view of a twisted and broken inserter tip during a procedure.It appears to still be inserted into the anchor.A visual inspection of the returned device found that it is not in its original packaging.The pieces of the inserter are twisted and broken.There is debris on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.Our medical investigation concluded: a review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of polymer found that the storage requirements, material specifications, and applicable tests were appropriately specified.A material certificate of analysis was required for the raw material.

• 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
• 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: 11963769
• Report Number: 1219602-2021-01317
• Device Sequence Number: 2990359
• Product Code: MBI
• UDI-Device Identifier: 03596010651280
• UDI-Public: 03596010651280
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K093428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2022

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: 12/16/2025
• Device Model Number: 72202397
• Device Catalogue Number: 72202397
• Device Lot Number: 2065655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/09/2021; 03/14/2022
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/21/2021; 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown