MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/25/2019
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.It was reported the facility will not release the device.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 that the patient underwent a rcr procedure on (b)(6) 2019 where a peek corkscrew suture anchor, ar-1927psf, and a pushlock suture anchor, ar-1926ps, were implanted.The surgery was completed with no issues.About two weeks later, the patient presented with pain in their shoulder in the general joint.The surgeon decided to remove the implants as the patient may have had an infection.During the revision, the medial implant was found to be a little loose but did not appear to be infected.Both implants explanted and the surgeon did not replace them with any hardware.The surgeon sent the implants to pathology for cultures and flushed the joint.Results from the cultures will be provided once available.Antibiotics were prescribed to the patient.Patient is a male, (b)(6).
Additional Manufacturer Narrative
The complaint was not confirmed.The damage was observed on the device that most likely occurred during removal.As stated in the event description, the reaction was likely not caused by the implant.

• Brand Name: SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9482955
• Report Number: 1220246-2019-01504
• Device Sequence Number: 19217886
• Product Code: HWC
• UDI-Device Identifier: 00888867023338
• UDI-Public: 00888867023338
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 08/31/2022
• Device Model Number: SUTURE ANCHOR, PUSHLOCK 3.5 X 19.5MM
• Device Catalogue Number: AR-1926PS
• Device Lot Number: 10162668
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR