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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET TRAUMA ADD 5MM IMPING 1ST ROD, FIXATION

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BIOMET TRAUMA ADD 5MM IMPING 1ST ROD, FIXATION Back to Search Results
Model Number N/A
Device Problems Difficult to Insert (1316); Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/25/2016
Event Type  malfunction  
Manufacturer Narrative
Current information is insufficient to permit a conclusion as to the cause of the event.
 
Event Description
It was reported that the endcap couldn't be inserted into the nail. The surgeon used and finished the surgery with an alternative one with no patient injury reported.
 
Manufacturer Narrative
This report is being submitted to reflect additional information not available at the time of the initial submission. Current information remains insufficient to determine the cause of the event. (b)(4).
 
Manufacturer Narrative
This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch. The end cap was received for evaluation. It was found that there is sufficient damage to the leading thread which likely was the cause of the device not being able to be inserted into the nail, thus the complaint is confirmed. The dimensions of the threads was not conducted as there was damage to the threads. The device history records were reviewed and no deviations or anomalies were identified. A definitive root cause of the reported issue cannot be determined with the information provided.
 
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Brand NameADD 5MM IMPING 1ST
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 Key6247637
MDR Text Key64723059
Report Number0001825034-2017-00047
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK033878
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 04/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number181701051
Device Lot NumberM06957 F
Other Device ID NumberSEE H10 NARRATIVE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2016
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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