MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ANCHOR PEG PERIPHERAL BIT; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number	2236-80-090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned devices confirmed the reported event.The investigation did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.(b)(4).
Event or Problem Description
It was reported that during a total shoulder replacement, the anterior peg peripheral bit ( 223680090 ) broke off midway down the threads of the drill bit, twice/ a different bits.The break left half of the threads in the global advantage at drill driver.We changed apg instruments.A surgical delay of five minutes.

• Brand Name: ANCHOR PEG PERIPHERAL BIT
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10676958
• Report Number: 1818910-2020-22256
• Device Sequence Number: 14188631
• Product Code: HTW
• UDI-Device Identifier: 10603295106319
• UDI-Public: 10603295106319
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 09/25/2020

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: 2236-80-090
• Device Catalogue Number: 223680090
• Device Lot Number: NG80813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1