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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. OFFSET END CAP 11X10MM .433D OFFSET; ROD, FIXATION Back to Search Results
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.
 
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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 Key12696591
MDR Text Key278336105
Report Number0001825034-2021-02946
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K091976
Number of Events Reported1
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 Number14-440072
Device Lot Number773890R
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 Received10/26/2021
Supplement Dates Manufacturer Received11/03/2021
Supplement Dates FDA Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H10
Patient SexMale
Patient Weight135 KG
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