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

Model Number 72203281

Device Problems Break (1069); Migration or Expulsion of Device (1395)

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

Event Date 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a dislocation of shoulder surgery, the anchor of the bioraptor fell off after implantation.The back up device was used in a new bone hole and all the pieces were removed from the patient by suction.Procedure was completed, after a non-significant delay, with a back-up device.The patient current status is okay.No other complications were reported.

Manufacturer Narrative

H2: additional information ¿b5, h6: medical device problem code¿.

Event Description

It was reported that during a dislocation of shoulder surgery, the anchor of the bioraptor fractured during the process of implantation, it was not completely implanted in the body.All the pieces were removed from the patient by suction.The back up device was used in a new bone hole.Procedure was completed, after a non-significant delay, with a back-up device.The patient current status is okay.No other complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).The reported device was received for evaluation.It was determined the device did not contribute to the reported event.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 the 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.A review of the customer provided image found anchor deployed from the device.The suture is still passing through the anchor, but no fracture can be seen.A visual inspection of the returned device found that it is not in its original packaging.The device has been deployed, and the suture is still passing through the anchor.There is a small fracture in the suture groove of the anchor.There is debris on the device.Based on the condition of the product material found during visual inspection, additional material testing is not required.Per case details, the broken parts were retrieved from the patient.The procedure was completed using a back-up device.It was also reported that an additional bone hole was required to complete the procedure and the impact to the patient is expected to be minimal.No further clinical/medical assessment is warranted at this time.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.

• Brand Name: BIORAPTOR CRV 2.3 PK SA UB COBRD BLUE
• Type of Device: 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: 13109117
• MDR Text Key: 282902850
• Report Number: 1219602-2021-02793
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010656469
• UDI-Public: 03596010656469
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203281
• Device Catalogue Number: 72203281
• Device Lot Number: 2065776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 55 KG