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

Model Number 510912

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

The complaint sample was not returned to greatbatch for evaluation so the reported event cannot be confirmed.A manufacturing review was completed and no discrepancies were found.If the complaint sample is returned, an evaluation will be performed and a supplemental 3500a emdr will be submitted.Complaint information provided by distributor, (b)(4).

Event Description

It was reported during an unknown procedure that the surgeon could not detach the inserter and had to use a reverse mallet, which broke the inserter.A small piece was left in the patient and the surgeon reported that this would cause no adverse effects to the patient.A surgical delay of 5 minutes was reported.The procedure was completed successfully.

• 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: 6827977
• MDR Text Key: 83901202
• Report Number: 3004976965-2017-00110
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 510912
• Device Catalogue Number: 510912
• Device Lot Number: 2937748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 54