MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR CRV 2.3 PK SA UB COBRD BLUE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203281
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
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 shoulder joint glenoid labrum repair surgery, the bioraptor anchor was pulled together with the needle.There was a 30 minute surgical delay as a new bone hole was drilled to place the backup device.A void bone hole was left in the patient.No further complications were reported.
Additional Manufacturer Narrative
H10 h3, h6 part of the reported device was received for evaluation.There was no way to determine if the device contributed to the reported event.A complaint history review found no 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.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 the customer provided image found a deployed anchor next to a bent shaft.No damage to the anchor can be seen in the image.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and no anchor or sutures were received.The shaft of the device is bent, and there is debris on the device.A functional evaluation could not be performed due to the condition in which the device was received.Per case details, the anchor was pulled out from the patient along with the needle.The procedure was completed using a back-up device.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted at this time.The complaint was not confirmed, and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that could have contributed to the reported event include inadequate bone quality, improper preparation of the insertion site, or off-axis insertion of the device.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.

• Brand Name: BIORAPTOR CRV 2.3 PK SA UB COBRD BLUE
• 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: 13479850
• Report Number: 1219602-2022-00174
• Device Sequence Number: 5085033
• Product Code: MBI
• UDI-Device Identifier: 03596010656469
• UDI-Public: 03596010656469
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 03/07/2026
• Device Model Number: 72203281
• Device Catalogue Number: 72203281
• Device Lot Number: 2069075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2021
• 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: Male
• Patient Weight: 87 KG