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

Model Number 510912

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned to greatbatch for evaluation therefore the reported event could not be confirmed.Thus, it is unknown if this device caused or contributed to the reported event.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.There have been no similar events reported to greatbatch for this device, or similar device, that has malfunctioned, due the threads compromising the trial, resulting death or serious injury due.However, due to the extended exposure of anesthesia of thirty (30) minutes and potential complications which can occur during a hip replacement procedure, this event is being reported solely due to the thirty (30) minute delay and not the malfunction, threads compromising the trial, as there have been no similar events reported that would likely to have caused or contributed to a death or serious injury.Lot number and device manufacturing date are unknown as the device and lot number were not available.Complaint information provided by distributor, (b)(4).

Event Description

It was reported during a total hip arthroplasty left hip, the impactor "compromised" (stripped) the threads of the window trial.The impactor would not engage the trial, leading to a 30 minute surgical delay to remove the trial.The surgery was successfully completed with no additional adverse events occurring due to the surgical delay.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: OFFSET 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: 7041456
• MDR Text Key: 92332063
• Report Number: 3004976965-2017-00121
• 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: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 510912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 55 YR