MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 3MM CROSS CONNECTOR DRIVER; WRENCH (RATCHETING HANDLES)

Catalog Number LV01548

Device Problem Fracture (1260)

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

Event Date 01/24/2020

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 the tip of the driver broke while tightening a cross connector during the procedure.The tip was retrieved and the standard cross connector wrench was used to complete the case without reported patient harm.

Event Description

It was reported that the tip of the driver broke while tightening a cross connector during the procedure.The tip was retrieved and the standard cross connector wrench 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.

Event Description

It was reported that the tip of the driver broke while tightening a cross connector during the procedure.The tip was retrieved and the standard cross connector wrench was used to complete the case without reported patient harm.

Manufacturer Narrative

The complaint is confirmed for one (1) of one (1) 3mm cross connector driver (pn: lv01548) for the failure of being fractured.The severity of this event is (b)(4).Medical records were not provided for review.Potential cause: cause can't be established since there is no information available regarding how the driver was being used or handled at the time of the damage.Complaint history: there were zero (0) other complaints for similar events (fracture) related to the same part number in the 12 months leading up to the notification date through to the present.Dhr review and related actions: a dhr review can't be performed since the lot number was not provided.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.

• Brand Name: 3MM CROSS CONNECTOR DRIVER
• Type of Device: WRENCH (RATCHETING HANDLES)
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9730891
• MDR Text Key: 180833872
• Report Number: 3012447612-2020-00068
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LV01548
• Device Lot Number: 312137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1