MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, HIP PUSHLOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, HIP PUSHLOCK
Health Effect - Clinical Codes	Inflammation (1932); Rash (2033)
Date of Event	11/01/2020
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 the patient is experiencing a rash approximately four weeks post op which went away with medication.The rash returned in (b)(6) of 2020.The rash is red and resembles hives and it is in the location of the hip and spreading to the upper thigh and also causing inflammation throughout the leg.The patient had a hip orthoscopy lateral repair (b)(6) 2019.Per the patient's comments, the recovery went as scheduled until the rash became evident.

• Brand Name: SUTURE ANCHOR, HIP PUSHLOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11476181
• Report Number: 1220246-2021-02729
• Device Sequence Number: 11772661
• Product Code: MAI
• UDI-Device Identifier: 00888867023130
• UDI-Public: 00888867023130
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K191679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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 Model Number: SUTURE ANCHOR, HIP PUSHLOCK
• Device Catalogue Number: AR-1923PHS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/12/2021
• 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