MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PROSTALAC MOLD SZ3 240 LT; HIP INSTRUMENTS : MOLDS

Catalog Number 254183000

Device Problem Difficult to Open or Close (2921)

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

Event Date 09/08/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: visual analysis of the returned sample 254183000/prostalac mold sz3 240 lt 4 exhibited that locator pin was visibly bent preventing to properly seat on the bottom mold.Also, overall device's edges presented several nicks most likely caused from another tool's interaction.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

Event Description

It was reported that the size 3 left 240mm mold would no longer fully closes.Mold was not used during the case.Defect was discovered during clean-up the day after the case.There was no surgical delay.

• Brand Name: PROSTALAC MOLD SZ3 240 LT
• Type of Device: HIP INSTRUMENTS : MOLDS
• 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: 15707228
• MDR Text Key: 307086665
• Report Number: 1818910-2022-21675
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254183000
• Device Lot Number: CV166497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• 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