MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BIO-COMP SWVLK SP, 4.75X24.5MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported via the patient's legal representative that the patient had undergone surgery on (b)(6) 2018 for rotator cuff and tendon repairs.According to the implant log provided the following arthrex devices were implanted: ar-2324bcct, biocomposite swivelock c (qty 1, lot # f171853) ar-2324bcm, biocomposite swivelock sp (qty 2, lot # f158844).According to the operative report, the surgeon implanted two (2) arthrex swivelock® anchors at the junction of the articular cartilage and the greater tuberosity.The arthrex fibertape was then passed through the torn rotator cuff, crisscrossed, and secured to bone with two (2) lateral arthrex suture anchors.This created closure of the tendon back down to bone.Although the operative report noted that a total of four (4) arthrex suture anchors were implanted, the implant log shows only three (3) anchors were used.Approximately two week post-op the patient had an x-ray taken and at the time of the x-ray the patient was reporting pain in the left shoulder.The x-ray findings indicated one of the surgical anchors was noted to project within the soft tissues on the ap view.The patient's (b)(6) 2018 physical therapy records note that the surgeon's nurse ordered all therapy to be held until the patient could get an mri.Records noted that it was believed the patient's anchor may have come loose requiring a possible additional surgery.On (b)(6) 2018 the patient underwent a second surgery.The procedure was performed as a removal only and no revision to the tendon was required.The operative report noted that an arthrex swivelock anchor had broken.The broken fragment and the remaining piece of anchor in bone were both removed from the patient.The report noted that the patient¿s rotator cuff was pristine with no sign of a recurrent tear.The removal operative report also noted that the previous fibertape sutures were seen, however, there was no mention of the sutures being removed.It is unknown which of the three original swivelock anchors was the one which broke and was removed.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9069854
• Report Number: 1220246-2019-01315
• Device Sequence Number: 1782370
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: 00888867026865
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 07/31/2019
• Device Model Number: BIO-COMP SWVLK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: F158844
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR