MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK C, CLD 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number BIO-COMP SWVLK C, CLD 4.75X19.1MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

Event Description

On 03/8/2024, it was reported by an arthrex subsidiary employee via email that (2) ar-2324bcc biocomposite swivelock pulled out of bone post operation.The revision surgery took place on (b)(6) 2024.The original procedure was performed on (b)(6) 2024.No further information was provided.Additional information requested.

Manufacturer Narrative

Additional information: b5, g4, h6.

Event Description

Additional information received on 4/19/2024: this was revision surgery took place on (b)(6) 2024.During the revision surgery, both ar-2324bcc biocomposite swivelock were explanted.

• Brand Name: BIO-COMP SWVLK C, CLD 4.75X19.1MM
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18951337
• MDR Text Key: 338260151
• Report Number: 1220246-2024-01588
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867026827
• UDI-Public: 00888867026827
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: BIO-COMP SWVLK C, CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC
• Device Lot Number: 15090891
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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): Other