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

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

Device Problem Flaked (1246)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during an elbow surgery the green plastic of the device chipped of inside the patient.No fragments remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

Complaint confirmed.One unpackaged ar-2324bcc-1 (no batch indicator present) was received for investigation.Visual inspection identified that the distal tip of the c8795 driver outer sleeve had ballooned out, with damage present along the diameter (investigation photo #3).The biocomposite screw and peek eyelet were present along the driver shaft.The distal-most threads of the biocomposite screw were stripped.The cause of the event remains undetermined.It was noted that the method used to prepare the bone, as well as the bone quality encountered during the procedure, were not recorded.As such, a probable cause can be attributed to improper bone preparation.

• Brand Name: BIO-COMP SWVLK C,CLD 4.75X19.1MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12362108
• MDR Text Key: 269604078
• Report Number: 1220246-2021-03544
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867097988
• UDI-Public: 00888867097988
• Combination Product (y/n): N
• PMA/PMN Number: K203495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BIO-COMP SWVLK C,CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC-1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/02/2021
• Patient Sequence Number: 1