MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK 3.5X 15.8MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK 3.5X 15.8MM
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Per sales representative, the surgeon reported that he implanted an expired implant into the patient in july.The patient got an infection but it is unclear if the infection was caused by the expired implant.Per system, the expiration date is 31-dec-2023 and was not expired during implantation.***update (b)(6) 2023 nroe: further information revealed that the part id was entered incorrectly.The expiration date of the correct part id is 31-may-2023, so the implant was in fact expired during implantation.The customer was repeatedly informed that the implant had expired.The procedure performed was an ac joint repair surgery.An additional surgery was performed at the end of august due to the infection.***update (b)(6) 2023 nroe: additional information was provided and revealed that in the additional surgery in august the infection was treated.Also it was reported that three other arthrex implants were implanted in the initial surgery in july.The implants were not removed.No further information received.
Additional 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.
Additional Manufacturer Narrative
The complaint allegation was confirmed by the customer's attached picture which displays the label of the product with the date of expiration.2023-10-31.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error due to abnormal use.Specifically, the error involved using and implanting an expired implant.Direction for use.Dfu-0087-13 at revision 0.Corkscrew®, pushlock®, and swivelock® suture anchors.K.Storage conditions.Non-bioabsorbable devices must be stored in the original unopened packaging, away from moisture and should not be used after the expiration date.

• Brand Name: BIO-COMP SWVLK 3.5X 15.8MM
• Common Device Name: 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: emily shafer ; 8009337001
• MDR Report Key: 18023719
• Report Number: 1220246-2023-08429
• Device Sequence Number: 7814717
• Product Code: MAI
• UDI-Device Identifier: 00888867283626
• UDI-Public: 00888867283626
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: BIO-COMP SWVLK 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC-1
• Device Lot Number: 14476887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 10/27/2023
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2021
• 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: Other
• Patient Sex: Unknown