MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SLOTTED MALLET W/DELRIN CAP; IMPACTOR

Catalog Number 270902006

Device Problems Break (1069); Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 doctor broke the hospital's mallet the week before.The synthetic wood had split.He asked the hospital to get him a new one, maybe with a rubber handle.So, they called and talked with the office and sent one to show to the head of surgery.Then, she showed it to the doctor and he liked it.They sterilized it and did an aml total hip.While broaching, the mallet broke or became loose.So, he sent it back expecting a replacement so i could use my po for the sale.But instead, they are looking for another one from a competitor and i am writing this.

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.

• Brand Name: SLOTTED MALLET W/DELRIN CAP
• Type of Device: IMPACTOR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11334756
• MDR Text Key: 232088940
• Report Number: 1818910-2021-03129
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 270902006
• Device Lot Number: SO2049734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 03/11/2021; 05/19/2021
• Supplement Dates FDA Received: 03/23/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1