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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA HIP FRACTURE NAIL RH 125 DEG 13MM X 400MM FIXATION, ROD

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BIOMET TRAUMA HIP FRACTURE NAIL RH 125 DEG 13MM X 400MM FIXATION, ROD Back to Search Results
Model Number N/A
Device Problem Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2016
Event Type  malfunction  
Manufacturer Narrative
Manufacture history has not been provided for review. Current information is insufficient to permit a conclusion as to the cause of the event. The following sections could not be completed with the limited information provided. Expiration date ¿ ni. Manufacture date ¿ ni.
 
Event Description
During a right hip fracture nail fixation procedure, the nail would not attach to the jig. Another nail was used to complete the procedure with minimal delay and no patient injury.
 
Manufacturer Narrative
Visual review of the returned device shows some staining which was likely a result of the decontamination process. Furthermore, there does not appear to be damage to the nail. A dimensional analysis was completed on the proximal end of the nail that connects with the jig. Two (2) of the slots on the proximal end of the nail measured undersized as well as the opening that connects to the jig. The dimensional analysis confirmed the complaint. The device is considered to be nonconforming as dimensions were out of spec with no visible damage that would have caused the nonconformities. Review of device history records found these units were released to distribution with no deviations or anomalies. Root cause was determined to be a manufacturing issue. Corrective and preventive actions have been initiated as a result of the nonconformance. F 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 NameHIP FRACTURE NAIL RH 125 DEG 13MM X 400MM
Type of DeviceFIXATION, ROD
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
megan haas
56 e. bell drive
warsaw, IN 46582
5743726700
MDR Report Key6001057
MDR Text Key56541873
Report Number0001825034-2016-03947
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
PK100238
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number814313400
Device Lot NumberDPFBWY
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2013
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

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