MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QR DRILL BIT 3.2MMX127MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number	2555-89-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2018
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
Instruments are broken and need to be replaced.Nothing fell into patient.No patient consequence and no surgical delay.One each impacted, one each needing replacement.No charge replacement for (b)(4) on po (b)(4) (prong used to remove liner broke off).No charge replacement for (b)(4) on po (b)(4) (only information given was that this was broken and missing from the set).Sold to (b)(4); ship to (b)(4).Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with the reported event was not returned for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QR DRILL BIT 3.2MMX127MM
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 7861521
• Report Number: 1818910-2018-68827
• Device Sequence Number: 1835669
• Product Code: HWT
• UDI-Device Identifier: 10603295142652
• UDI-Public: 10603295142652
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2018
• 2 Devices were Involved in the Event: 1 2

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: 2555-89-000
• Device Catalogue Number: 255589000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 02/23/2022
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 12/13/2018; 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown