MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 10 X 150MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that patient sustained mechanical breakage of nails in the post operative period.Attempts were made to gain more information however, no information was received.

Event Description

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

Manufacturer Narrative

(b)(4).Concomitant medical products : 27914  lag screw guide wire 3.2x460mm 980630 , 27914  lag screw guide wire 3.2x460mm 765620 , 27984  4.3mm crowe point twist drill 809470 , 41010  calibrated drill 4.3mm 809760 , 14-440118 ankle locking nail 10 x 180mm 518700,  14-405046 ti-dble lead cort 5.0x46mm scr 729640 , 14-405065 ti-dble lead cort 5.0x65mm scr 670000 , 14-405028 ti-dble lead cort 5.0x28mm scr 374520 , 14-405050 ti-dble lead cort 5.0x50mm scr 783290 , 14-410002 bead tip gd wire 2.6mm x 80cm 337180 .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: 0001825034-2019-04548 and 0001825034-2019-04549.

Event Description

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

Manufacturer Narrative

(b)(4).Reported event was considered confirmed as the radiographs show a fracture.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: ANKLE LOCKING NAIL 10 X 150MM
• Type of Device: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8647854
• MDR Text Key: 146372263
• Report Number: 0001825034-2019-02314
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K081243
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• 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: 14-440115
• Device Lot Number: 980500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other