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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA UNKNOWN BIOMET AFFIXUS HIP FRACTURE NAIL INSERTION JIG BOLT

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BIOMET TRAUMA UNKNOWN BIOMET AFFIXUS HIP FRACTURE NAIL INSERTION JIG BOLT Back to Search Results
Model Number N/A
Device Problems Failure to Disconnect (2541); Device Operational Issue (2914)
Patient Problem No Information (3190)
Event Date 06/28/2017
Event Type  Injury  
Manufacturer Narrative
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Product has been returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. The returned device is one 125-degree affixus hip fracture nail, pn 814309180 ln 5550103, along with the associated 125-degree targeting jig and connecting bolt. Visually, the nail and jig are unremarkable, with a small amount of cosmetic wear likely due to implantation, explantation, and sterilization. The connecting bolt shows wear - but not to the point of being stripped. Functional testing reveals the bolt to be fused to the nail, confirming this complaint. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. Review of the complaint history could not be performed, as the part and lot numbers are unknown. Root cause was unable to 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.
 
Manufacturer Narrative
(b)(6). Medical product - insertion jig 125 degree, cat#: 211201200 lot#: e73df4. 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. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05191.
 
Event Description
It was reported that during a hip fracture nailing procedure, the connecting jig bolt was locked in the nail and could not be dislodged or removed. As a result, the entire system had to be removed from the patient. A competitor product was used to complete the procedure with minimal delay. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN BIOMET AFFIXUS HIP FRACTURE NAIL INSERTION JIG BOLT
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 Key6739503
MDR Text Key109915249
Report Number0001825034-2017-05197
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
PEXEMPT
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
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2017
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? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/25/2017 Patient Sequence Number: 1
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