MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID,LG VER GD,15,0,-20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNI GLENOID,LG VER GD,15,0,-20
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow up will be submitted.
Event or Problem Description
It was reported that the device did not drill correctly into the bone and got stuck in the central hole.Metal abrasion was produced.Nothing remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.The shoulder prosthesis surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed, the inferior side of the central hole id was found to have circumferential abrasion marks and damaged, causing it to be undersized.The undamaged section of the central hole id was found to meet specifications.The damage is consistent with another object grinding, thus the cause is likely to be prying/leveraging the drill bit during use.

• Brand Name: UNI GLENOID,LG VER GD,15,0,-20
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11761743
• Report Number: 1220246-2021-03014
• Device Sequence Number: 4015755
• Product Code: LXH
• UDI-Device Identifier: 00888867057562
• UDI-Public: 00888867057562
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UNI GLENOID,LG VER GD,15,0,-20
• Device Catalogue Number: AR-9125-30
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/08/2021
• Patient Sequence Number: 1