MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. STRAIGHT RATCHET HANDLE WITH A/O CONNECTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 07.00438.001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that during a routine inspection, it was found a ratcheting handle did not fit well with its mating part and felt like it was grinding.A patient was not involved with this event.

Manufacturer Narrative

The returned handle was examined.The handle would not lock onto the driver; the driver fell out without the quick connect sleeve pulled back to allow for disconnection.The cause is likely attributed to normal wear and tear of the device from repetitive use over the years the device has been available for use.A review of the dhr did not identify any manufacturing related issues which would have contributed to this event.

Event Description

It was reported that during a routine inspection, it was found a ratcheting handle did not fit well with its mating part and felt like it was grinding.A patient was not involved with this event.

• Brand Name: STRAIGHT RATCHET HANDLE WITH A/O CONNECTOR
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7491066
• MDR Text Key: 107505779
• Report Number: 3012447612-2018-00415
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.00438.001
• Device Lot Number: P080512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1