MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN IMPACTOR HEAD; INSTRUMENT, SURGICAL

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical devices: targeting guide catalog#: 00249000300 lot#: 62186171.It is unknown if the product will be returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that during a procedure while the surgeon attempted to insert the nail the threads of the impaction head fractured in the guide.No adverse events were a result of this malfunction.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection indicated the threads of the impactor head have fractured off and are retained in the jig handle.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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: UNKNOWN IMPACTOR HEAD
• Type of Device: INSTRUMENT, SURGICAL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7965710
• MDR Text Key: 123944443
• Report Number: 0001822565-2018-05722
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1