MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number AR-2323BCC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Edema (1820); Erythema (1840); Swelling (2091)

Event Date 01/07/2020

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.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that a patient underwent a shoulder repair surgery on (b)(6) 2020 in which ar-2324bct-2 & ar-2323bct-2 were implanted.The patient has been experiencing post-op symptoms of redness, swelling and draining.The patient has been referred to an immunologist.The immunologist is requesting sample product of ar-2324bct-2 & ar-2323bct-2.The immunology appointment is scheduled for (b)(6) 2020.Additional information has been requested.Additional information received on 4/01/2020: the original procedure performed was a left rotator cuff repair (two anchors suture bridge) subacromial decompression and sub pectoralis biceps tenodesis.The facility reported ar-2324bct-2 (lot: 10431237) & ar-2323bct-2 (lot: 10268328) were the only artrhex products implanted during the procedure.The patient's symptoms first started on (b)(6) 2020.Postoperatively, the patient developed cellulitis overlying their left shoulder and upper arm.The patient was initially placed on keflex which did not seem to improve their symptoms and was then transitioned to clindamycin again with no significant changes.The patient was then referred to infectious disease who started them on iv vancomycin.Again there was no significant changes in their symptoms.An mri with and without contrast was obtained to the left shoulder that demonstrated some fluid within the subacromial space and surgical field and associated bony edema.The mri was inconclusive for infection versus standard postoperative changes.An aspiration was performed of the subacromial space which on extended final cultures was negative.Due to the patient's history of multiple infections after other surgeries and persistent symptoms with the left shoulder girdle patient was returned to the operating room on (b)(6) 2020 for left shoulder arthroscopic i&d, cultures and tissue biopsies.Extended final cultures and tissue biopsies from the patient's repeat surgical intervention were negative.

Manufacturer Narrative

This supplemental submission is to correct the device part number from the original submission (1220246-2020-1800) to reflect the new device part number of ar-2323bcc, with a device product code of mai with a 510(k) of k191226 and udi #(b)(4).

Event Description

Additional information received: received confirmation from facility that the original part numbers provided were incorrect.The part numbers have been changed to the correct product (ar-2323bcc / lot: 10268328 and ar-2324bcc / lot: 10431237).

• Brand Name: BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9985407
• MDR Text Key: 191128083
• Report Number: 1220246-2020-01800
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: 00888867251236
• Combination Product (y/n): N
• PMA/PMN Number: K191226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR-2323BCC
• Device Catalogue Number: AR-2324BCT-2
• Device Lot Number: 10268328
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 98