MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLO ANCHOR PEG GLENOID 52 TRL; EXTREMITY INSTRUMENTS : GLENOID TRIALS

Model Number	2236-80-030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the peripheral peg broke off during removal of apg trial.Broken piece was retrieved.No lot # on instrument.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was returned, however a photo was provided for review confirming the reported event.Depuy considers the investigation closed at this time.Should the additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: GLO ANCHOR PEG GLENOID 52 TRL
• Common Device Name: EXTREMITY INSTRUMENTS : GLENOID TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10522124
• Report Number: 1818910-2020-19882
• Device Sequence Number: 19612505
• Product Code: LXH
• UDI-Device Identifier: 10603295106241
• UDI-Public: 10603295106241
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 2236-80-030
• Device Catalogue Number: 223680030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR