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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA AFFIXUS HIP FRACTURE NAIL - RIGHT 130 DEGREES ROD, FIXATION

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BIOMET TRAUMA AFFIXUS HIP FRACTURE NAIL - RIGHT 130 DEGREES ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Separation Failure (2547)
Patient Problem No Information (3190)
Event Date 07/12/2017
Event Type  Injury  
Manufacturer Narrative
Complaint sample was evaluated and the reported event was not confirmed. The returned devices are one insertion jig bolt, pn 211201202 ln so2001775, one hfn rh 130 deg 11mm x 340mm, pn 814511340 ln 214510, and one insertion jig 130 degree, pn 211201201 ln cx3227m01. A postmarket surveillance technician was able to remove the reported nail from the targeting jig with a moderate amount of force. Visual examination showed a considerable amount of biological matter on the threads of the jig bolt, but no visible damage. Once the both and the nail were cleaned, they assembled and disassembled without issue. Dhr was reviewed and no discrepancies relevant to the reported event were found. Based on the fact that the devices mated as expected once cleaned, it is believed the biological matter on the jig bolt caused it to stick. 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
Pt identifier: - (b)(6). Concomitant medical product: - insertion jig 125 degree, cat#: 211201200 lot#: ni. Hfn rh 130 deg 11mm x 320mm, cat#: 814511320 lot#: 5491807. T-handle hudson, cat#: 281001004 lot#: ni. A 5. 0mm hex driver long, cat#: 281001037 lot#: ni. Insertion jig 130 degree, cat#: 211201201 lot#: cx3227m01. Product has been 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: 0001825034-2017-06648 and 0001825034-2017-06649.
 
Event Description
It was reported that during a hip fracture repair nailing procedure, the jig could not be disassembled from the implanted nail. This caused the surgeon to remove both the lag screw and hip fracture nail from the patient. A 125 degree nail was successfully implanted, but the lag screw hole had to be expanded to accommodate a different angle. There was an approximate thirty (30) minute delay to the procedure. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand NameAFFIXUS HIP FRACTURE NAIL - RIGHT 130 DEGREES
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 Key6825781
MDR Text Key254994819
Report Number0001825034-2017-06648
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814511340
Device Lot Number214510
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 Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2013
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: 08/28/2017 Patient Sequence Number: 1
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