MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX SUTURE KIT; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	UNIVERS APEX SUTURE KIT
Health Effect - Clinical Codes	Abscess (1690); Swelling (2091)
Date of Event	11/21/2019
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.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 fda medwatch letter (mw5091542) that the following incident occurred: patient was having total shoulder procedure.A drill bit was used.The tip broke off and was not noticed.Post op visit shoulder was tender and swollen.X-ray film showed approximately 1.5 cm drill tip in shoulder.Ct showed abscess.The fda medwatch letter did not contain any facility or reporter name or contact information.No follow up is possible at this time.

• Brand Name: UNIVERS APEX SUTURE KIT
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9631316
• Report Number: 1220246-2020-01594
• Device Sequence Number: 14120271
• Product Code: GAT
• UDI-Device Identifier: 00888867197435
• UDI-Public: 00888867197435
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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: 04/30/2024
• Device Model Number: UNIVERS APEX SUTURE KIT
• Device Catalogue Number: AR-7298
• Device Lot Number: 10307244
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other