MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Z NAIL CPM 10MM X 38CM 125 L; ROD, FIXATION

Catalog Number 47-2493-381-10

Device Problem Fracture (1260)

Patient Problem Non-union Bone Fracture (2369)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-07163.Udi: (b)(4).Medical devices: z nail 10.5 x 95 lag screw cat: 47-2485-095-10 lot: 2935501; z nail 5.0x57.5 cort screw fa cat: 47-2484-057-50 lot: 62287327; z nail 5.0x37.5 cort screw fa cat: 47-2484-037-50 lot: 63641845; z nail 5.0x35 cort screw fa cat: 47-2484-035-50 lot: 63711975; 3.2mm threaded pin cat: 00-2490-450-32 lot: unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that the patient underwent a revision procedure due to non union and fracture of the implant.During the procedure, it was noted that the lag screw was retroverted.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Upon receipt of additional information it has been determined that the device will be reported on mfr#: 9613350.Therefore, the event is not reportable on mfr #: 0001822565.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

Upon receipt of additional information it has been determined that the device will be reported on mfr#: 9613350.Therefore, the event is not reportable on mfr #: 0001822565.

• Brand Name: Z NAIL CPM 10MM X 38CM 125 L
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8206370
• MDR Text Key: 131721874
• Report Number: 0001822565-2018-07164
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• 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: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47-2493-381-10
• Device Lot Number: 2808701R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention