MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MODULAR CENT EPI TRIAL SZ1; EXTREMITY INSTRUMENTS : EPIPHYSIS TRIAL

Model Number	2307-20-101
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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
Delta xtend locking screwdriver was missing one of the 'castles' that connects the handle to the screw.Was picked up at the beginning of the case upon inspection.Epipyhsis trial was missing the screw that locks it to the stem trial; this also was picked up at the beginning of the case.
Additional Manufacturer Narrative
Product complaint # (b)(4).Coding has been updated from broken (2+ pieces): pre or post operatively/step unknown to visual: missing components.Depuy-synthes does not consider this a reportable event at this time.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: MODULAR CENT EPI TRIAL SZ1
• Common Device Name: EXTREMITY INSTRUMENTS : EPIPHYSIS TRIAL
• 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 46580 ; 3035526892
• MDR Report Key: 16069541
• Report Number: 1818910-2022-26256
• Device Sequence Number: 12320612
• Product Code: HWT
• UDI-Device Identifier: 10603295115717
• UDI-Public: 10603295115717
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 12/29/2022

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: 2307-20-101
• Device Catalogue Number: 230720101
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/30/2023
• 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