MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US GLO ADV STRAIGHT DRILL DRIVER; DRILLS (BITS, SLEEVES, GUIDES) : DRILL/DRIVER SHAFTS

Model Number	2128-61-012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(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 instrument from out of office set has a broken tip.No surgery affected.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :examination of the returned device did not find any evidence of malfunction or product error.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 ADV STRAIGHT DRILL DRIVER
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILL/DRIVER SHAFTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10462547
• Report Number: 1818910-2020-18959
• Device Sequence Number: 2939127
• Product Code: HWR
• UDI-Device Identifier: 10603295089346
• UDI-Public: 10603295089346
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 2128-61-012
• Device Catalogue Number: 212861012
• Device Lot Number: SO2016595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1