MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN DRILL PIN AND SCREW INSERTER; KNEE INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Reporter had indicated that product will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the device fractured.Another device was used to complete the surgery.

Manufacturer Narrative

This follow-up report is being submitted to relay updated and additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned inserter identified that part the hex head of an unknown pin had fractured off and was stuck in the inserter¿s 2.5mm hex feature.The inserter also shows signs of wear indicative of repeated use.The rest of the fractured pin was not returned.Dhr was reviewed and no discrepancies were found.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 00959.

Event Description

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

• Brand Name: NEXGEN DRILL PIN AND SCREW INSERTER
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7468010
• MDR Text Key: 106719879
• Report Number: 0001822565-2018-02411
• Device Sequence Number: 1
• Product Code: HWB
• 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,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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
• Device Catalogue Number: 00590102100
• Device Lot Number: 63753371
• Other Device ID Number: (01)00889024201637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1