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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA US NANCY NAIL 450 25/10 ROD, FIXATION

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BIOMET TRAUMA US NANCY NAIL 450 25/10 ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 05/02/2017
Event Type  Injury  
Manufacturer Narrative
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
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. The distal nail tip fractured approximately 8mm from the distal end. The longer section¿s distal fracture surface has fracture artifacts that suggest a two-way bending fatigue fracture. The shorter nail section shows numerous gouges, scrapes, and signs of contact with hard objects. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. 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
This follow-up report is being submitted to relay additional information. 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)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. This device is not manufactured by zimmer biomet us; however, this report is being filed as zimmer biomet in (b)(4), in manufactures a similar device under 510k number k993956.
 
Event Description
It is reported that during a trauma flexible nailing procedure, the nail tip fractured intra-operatively. All pieces were not able to be retrieved, as some of the nail remained stuck in the patient's bone. No further patient consequences have been reported at this time. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information. (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.
 
Event Description
It is reported that during a trauma flexible nailing procedure, the nail tip fractured intra-operatively while repositioning the fracture site. The fractured nail was able to be removed without issue, and a new nail was placed. No further patient consequences have been reported at this time. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUS NANCY NAIL 450 25/10
Type of DeviceROD, FIXATION
Manufacturer (Section D)
BIOMET TRAUMA
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6604417
MDR Text Key120306658
Report Number0001825034-2017-03501
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
PN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberM21930
Device Lot Number5230165
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2014
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

Patient Treatment Data
Date Received: 06/01/2017 Patient Sequence Number: 1
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