MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLC DRILL BIT 3.8 DIA 40MM; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

Model Number	2274-12-000
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent the tha surgery for oa with the drill bits in question.In the surgery, a total of 4 drill bits were deformed or broken when drilling screws for the acetabular cup.The bone quality was so hard.The surgery was completed successfully less than 30 minutes surgical delay.No further information is available.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Evaluation of the dlc drill bit 3.8 dia 40mm can confirm the reported event.The device is found bent, also the tip of the device is broken, all pieces were returned for evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: DLC DRILL BIT 3.8 DIA 40MM
• 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 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15978804
• Report Number: 1818910-2022-25349
• Device Sequence Number: 12227132
• Product Code: HTW
• UDI-Device Identifier: 10603295109082
• UDI-Public: 10603295109082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/14/2022

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: 2274-12-000
• Device Catalogue Number: 227412000
• Device Lot Number: NG57917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 02/21/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/12/2023; 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown