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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. JUGGERLOC BONE TO BONE TITANIUM KIT WASHER, BOLT NUT

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ZIMMER BIOMET, INC. JUGGERLOC BONE TO BONE TITANIUM KIT WASHER, BOLT NUT Back to Search Results
Model Number N/A
Device Problems Migration or Expulsion of Device ; Difficult to Remove
Event Date 11/13/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Customer has been 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. Remains implanted.

 
Event Description

It was reported that during an ankle syndesmosis procedure, while tightening the washer following anchor fixation, intraoperative x-rays showed evidence that the anchor had pulled out of the bone. A different syndesmosis product had to be opened and the bone had to be re-drilled. The prior anchor was lodged in the syndesmosis space and could not be removed, reportedly leading to some difficulty passing the new device. Attempts have been made and additional information on the reported event is unavailable.

 
Manufacturer Narrative

(b)(4). The following report is submitted to relay additional information. The reported event could not be confirmed based on limited information received. No products were returned; therefore, the visual and dimensional inspections were not performed. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. A definitive root cause cannot be determined with the information provided. No corrective actions, preventive actions, or field actions resulted after investigation of this event. 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.

 
Manufacturer Narrative

(b)(4). 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.

 
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Brand NameJUGGERLOC BONE TO BONE TITANIUM KIT
Type of DeviceWASHER, BOLT NUT
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 Key7112955
Report Number0001825034-2017-10999
Device Sequence Number1
Product CodeHTN
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/08/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number110007345
Device LOT Number544980
OTHER Device ID NumberSEE H10 NARRATIVE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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