MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER OFFSET STEM DRIVER; HIP INSTRUMENTATION

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during an initial surgery, upon insertion of broach, a piece of the stem driver's handle broke off.There was no delay in surgery.No fragments of broken instrument fell into patient.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation.As returned, the blue handle sleeve is fractured.The device exhibits wear & tear.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER OFFSET STEM DRIVER
• Type of Device: HIP INSTRUMENTATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7304471
• MDR Text Key: 101276716
• Report Number: 0001822565-2018-01081
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00771205710
• Device Lot Number: 61902304
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ITEM #00771205710, STEM DRIVER, LOT #61902304
• Patient Age: 49 YR