MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN FEMORAL SET SCREW HEX DRIVER TORQUE LIMITING SIZE 2.0 MM; INSTRUMENTS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign: (b)(6).The complainant has indicated that the product will return to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Investigation incomplete.

Event Description

It was reported that during surgery a hex screw driver broke during stubby fixation on a persona tibia.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

Visual examination of the returned product identified a hex feature sign of repeated use and the instrument was fractured.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Medical records were not provided.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The complaint is confirmed.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.

Event Description

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

• Brand Name: NEXGEN FEMORAL SET SCREW HEX DRIVER TORQUE LIMITING SIZE 2.0 MM
• Type of Device: INSTRUMENTS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11278816
• MDR Text Key: 230252168
• Report Number: 0001822565-2021-00307
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

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: 00598707100
• Device Lot Number: 63967070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1