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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP GENERAL OFFSET-30° BROACH HANDLE - LEFT SURGICAL INSTRUMENT FOR HIP SURGERY

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MEDACTA INTERNATIONAL SA HIP GENERAL OFFSET-30° BROACH HANDLE - LEFT SURGICAL INSTRUMENT FOR HIP SURGERY Back to Search Results
Catalog Number 01.10.10.131
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 01/29/2019
Event Type  malfunction  
Manufacturer Narrative
Batch review performed on 25 february 2019: lot 1111995c: (b)(4) items manufactured and released on 10-apr-2018. No anomalies found related to the problem. To date, no other similar event has been reported on this lot.
 
Event Description
During the impaction the ball of the broach handle fell out from the passing hole and the spring was broken, no debris fell in the patient. There was a delay of max. Five minutes.
 
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Brand NameHIP GENERAL OFFSET-30° BROACH HANDLE - LEFT
Type of DeviceSURGICAL INSTRUMENT FOR HIP SURGERY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, switzerland 6874
SZ   6874
MDR Report Key8377334
MDR Text Key139072318
Report Number3005180920-2019-00097
Device Sequence Number1
Product Code LHX
Combination Product (y/n)N
Reporter Country CodeGM
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 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number01.10.10.131
Device Lot Number1111995C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/10/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/28/2019 Patient Sequence Number: 1
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