MAUDE Adverse Event Report: SYNTHES DHS SYSTEM - IMPACTOR

Catalog Number 338-26

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2016

Event Type  malfunction  

Event Description

Using the synthes dhs impactor, the impactor device cracked and broke during use.Removed all broken pieces from sterile field and retained for sale rep pickup.No harm caused to pt.

• Brand Name: DHS SYSTEM - IMPACTOR
• Type of Device: DHS SYSTEM - IMPACTOR
• Manufacturer (Section D): SYNTHES; west chester
• MDR Report Key: 6217867
• MDR Text Key: 63836720
• Report Number: MW5067004
• Device Sequence Number: 1
• Product Code: HWA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2016

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: 338-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1