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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS BROACH HANDLE; SURGICAL INSTRUMENT FOR HIP SURGERY
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MEDACTA INTERNATIONAL SA AMIS BROACH HANDLE; SURGICAL INSTRUMENT FOR HIP SURGERY Back to Search Results
Catalog Number 01.15.10.0131
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/16/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 26 july 2019.Lot 1755689: (b)(4) items manufactured and released on 03-july-2018.No anomalies found related to the problem.To date, no other similar events have been reported.
 
Event or Problem Description
During hammering the ball spring mechanism broke, the ball felt out from the broach handle.The ball did not fall in the patient.A second instrument was used to complete the surgery.
 
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Brand Name
AMIS BROACH HANDLE
Common Device Name
SURGICAL INSTRUMENT FOR HIP SURGERY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8883094
Report Number3005180920-2019-00673
Device Sequence Number16199772
Product Code LXH
UDI-Device Identifier07630040768672
UDI-Public07630040768672
Combination Product (Y/N)N
Initial Reporter CountryGM
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number01.15.10.0131
Device Lot Number1755689
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/16/2019
Initial Report FDA Received Date08/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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