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

Model Number 255000115

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint sample has not been received at integer for evaluation.Once the complaint sample is received, an evaluation will be performed and a supplemental medwatch 3500a emdr will be submitted.Unknown as the lot number has not been provided by the initial reporter at this time, nor has the device been returned for evaluation.Complaint information provided by distributor, depuy orthopaedics.

Event Description

It was reported during an unknown patient procedure the cup inserter threads not disengaging the cup.No adverse events nor patient consequence were reported as a result of the malfunction.

Manufacturer Narrative

The complaint sample was received incomplete (no impactor tip) at integer for evaluation and the reported event was not confirmed.A cup simulant was used to simulate attachment and detachment of a cup during surgery.The cup was attached and detached following instructions for use (ifu) that were sent with this device.No issues were observed.The cup simulant attached and detached as intended.There were minimal material deformities observed on the threads, consistent with wear, which did not affect the function of the device.Other observations: there were many signs of wear in the form of scratches, nicks and gouges throughout the complaint sample; the weld around the ratchet housing was partially cracked, however, during the aforementioned simulation, no functional issues were observed; there was material deformation observed on the blue knob, potentially caused by pliers or some item clamping down on the knob, which is not consistent with intended use; the returned complaint sample was etched per applicable drawings.In summary, the reported event is unconfirmed as no issues were observed when attaching and detaching a cup simulant.The device was worn but functional.No further investigation is required.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: CUP IMPACTOR
• Manufacturer (Section D): GREATBATCH MEDICAL; 4545 kroemer road; fort wayne IN 46818
• MDR Report Key: 7508203
• MDR Text Key: 108258877
• Report Number: 3004976965-2018-00033
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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 Model Number: 255000115
• Device Catalogue Number: 511172
• Device Lot Number: PC2883760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 06/22/2018
• Supplement Dates FDA Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR