MAUDE Adverse Event Report: ZIMMER BIOMET, INC. OFFSET END CAP 11X10MM .433D OFFSET; ROD, FIXATION

Catalog Number 14-440072

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source foreign: (b)(6).Concomitant medical products: ankle locking nail 12 x 210mm cat: 14-440321 lot: 028130.Ti-dble lead cort 5.0x28mm scr cat: 14-405028 lot: 101720.Ti-dble lead cort 5.0x28mm scr cat: 14-405028 lot: 907050.Ti-dble lead cort 5.0x46mm scr cat: 14-405046 lot: 916480.Ti-dble lead cort 5.0x75mm scr cat: 14-405075 lot: 729800r.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 report will be submitted.

Event Description

It was reported that the patient underwent an initial right ankle procedure.Subsequently, the implants disassembled.No revision procedure has been indicated at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: displacement of the nail end cap at the calcaneus.No fracture or other abnormality is noted and alignment is maintained.A small amount of radiolucency is noted along the distal nail and end cap.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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.

Event Description

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

• Brand Name: OFFSET END CAP 11X10MM .433D OFFSET
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12696591
• MDR Text Key: 278336105
• Report Number: 0001825034-2021-02946
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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 Catalogue Number: 14-440072
• Device Lot Number: 773890R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Sex: Male
• Patient Weight: 135 KG