MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ANKLE LOCKING NAIL 10 X 180MM; PROSTHESIS SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi#: n/a concomitant medical product: 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.  14-440115,ankle locking nail 10 x 150mm,980500.  14-440118,ankle locking nail 10 x 180mm,unk.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.  customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: 0001825034-2019-02314 and 0001825034-2019-04549.

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).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 180MM
• Type of Device: PROSTHESIS SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9166783
• MDR Text Key: 204600606
• Report Number: 0001825034-2019-04548
• 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
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 14-440118
• Device Lot Number: 518700
• 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