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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 - RIGHT; SURGICAL INSTRUMENT FOR HIP SURGERY
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MEDACTA INTERNATIONAL SA HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT; SURGICAL INSTRUMENT FOR HIP SURGERY Back to Search Results
Catalog Number 01.10.10.130
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Batch review performed on 05 july 2019: lot: 1210183d: (b)(4) item manufactured and released on 4-mar-2019.No anomalies found related to the problem.No similar event reported on this batch.Visual inspection performed on 22-july-2019: the spring ball plunger is came apart.It is possible this occurrence was influenced by variation in production/assembly however this cannot be confirmed.Evaluation of the solution on going.
 
Event or Problem Description
During the surgery the instrument lever locking ball fell out of the instrument.It didn't fell in the patient.The surgery was completed successfully using a back-up handle.
 
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Brand Name
HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT
Common Device Name
SURGICAL INSTRUMENT FOR HIP SURGERY
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key8816678
Report Number3005180920-2019-00601
Device Sequence Number11519982
Product Code LXH
UDI-Device Identifier07630040742115
UDI-Public07630040742115
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) 07/23/2019
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 Number01.10.10.130
Device Lot Number1210183D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2019
Initial Report FDA Received Date07/23/2019
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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