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

Model Number 2307-20-101

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 306609346
• Report Number: 1818910-2022-26256
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1