MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. RATCHET HANDLE-T; WRENCH (RATCHETING HANDLES)

Catalog Number 124797

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 the procedure the handle would not ratchet while inserting a screw.An alternate handle, from a different set, was used to complete the case without reported patient harm.

Event Description

It was reported that during the procedure the handle would not ratchet while inserting a screw.An alternate handle, from a different set, was used to complete the case without reported patient harm.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow-up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The complaint is unconfirmed for one (1) of one (1) returned ar ratchet scr inserter t-hndl (pn: 124797) for the failure of device not ratcheting.The severity of this event is 0 (rmr-00090).Medical records were not provided for review.Potential cause: the devices was able to function as expected.There are no problem detected.Complaint history: there were zero (0) other complaints for similar events (instruments break, bend, twist, deform, or jam) related to the same part number or any associated lot numbers since the lot was released leading up to the notification date through to the present.Dhr review and related actions: the dhr for this lot was unable to be found.Actions have been taken as part of (b)(4)to address this issue for dhrs going forward.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility: this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.

Event Description

It was reported that during the procedure the handle would not ratchet while inserting a screw.An alternate handle, from a different set, was used to complete the case without reported patient harm.

• Brand Name: RATCHET HANDLE-T
• Type of Device: WRENCH (RATCHETING HANDLES)
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9919211
• MDR Text Key: 187427703
• Report Number: 3012447612-2020-00199
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 124797
• Device Lot Number: 22221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1