MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DRILL BIT 3.2 DIA 25MM LENGTH; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number	2366-86-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill bit is broken.No adverse effects to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device was received for examination; therefore, the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre) was not possible because the required lot code was not provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Replaced break (intraoperatively) with break (intraoperatively : fragment removed from wound).
Event or Problem Description
A.Was there a surgical delay? if yes, what is the duration of the delay? no.B.Did it break in two or more pieces? if yes, were all pieces retrieve from the patient? yes two parts.Yes all retrieved from the patient.C.Which part did it broke? the end.
Event or Problem Description
Additional information received.A.Was there a surgical delay? if yes, what is the duration of the delay? -no b.Did it break in two or more pieces? if yes, were all pieces retrieve from the patient? -yes two parts.Yes all retrieved from the patient c.Which part did it broke? -the end.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DRILL BIT 3.2 DIA 25MM LENGTH
• Common Device Name: DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14597000
• Report Number: 1818910-2022-10088
• Device Sequence Number: 19356663
• Product Code: HTW
• UDI-Device Identifier: 10603295120209
• UDI-Public: 10603295120209
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 06/03/2022
• 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: 2366-86-000
• Device Catalogue Number: 236686000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 06/06/2022; 06/06/2022; 06/16/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/07/2022; 06/08/2022; 06/17/2022
• 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