MAUDE Adverse Event Report: GREATBATCH MEDICAL METAL HANDLE OFFSET CUP IMPACTOR

Model Number 255000115

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to greatbatch for evaluation therefore the reported event could not be confirmed.The manufacturing records were not reviewed as the lot number was not provided.If the device is returned, the evaluation will be performed and a supplemental medwatch 3500a emdr will be submitted.Lot number not provided by distributor after multiple attempts have been made.Complaint information provided by distributor, (b)(4).

Event Description

It was reported during an unknown procedure that after threading the cup on to the offset impactor handle and applying blows to seat the cup, the cup became stuck.The surgeon was unable to remove the cup resulting in a new tray being opened as well as a new implant.There was a 15 minute delay.No adverse events were reported as a result of the malfunction.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: CUP IMPACTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 4545 kroemer road; fort wayne IN 46818
• Manufacturer (Section G): GREATBATCH MEDICAL; 4545 kroemer road; fort wayne IN 46818
• Manufacturer Contact: tony singh ; 4545 kroemer road; fort wayne, IN 46818 ; 2607557466
• MDR Report Key: 6913582
• MDR Text Key: 88154553
• Report Number: 3004976965-2017-00114
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255000115
• Device Catalogue Number: 511172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• 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: Reuse
• Patient Sequence Number: 1