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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. DELTA CURVED IMPACTOR

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LIMACORPORATE S.P.A. DELTA CURVED IMPACTOR Back to Search Results
Model Number 9055.51.035
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The check of the dhr of the lot # involved did not show any pre-existing anomaly on the 11 pieces of delta cup curved impactor manufactured with lot #201402401. This is the first and only complaint received on this lot#. Limacorporate received and analyzed the cup impactor. A visual analysis confirmed that the impact surface (or flange) is broken and detached from the impactor body; detachment of the flange occurred corresponding to the welding between flange and body. A technical analysis carried out on the instrument showed that: the welding of the flange to the impactor body was performed according to specifications; no manufacturing process deficiency was detected; the flange appears to be heavily deformed likely due to repeated off-axis impacts; the repeated off-axis impacts could have significantly led to the failure of the welding. We don't know how many times this impactor, manufactured in 2014, has been used before breaking; it is possible that, when impacting the cup, the instrument was subjected to multi-axial forces and repeated stresses that could have contributed over time to the breakage of the impact surface. Pms data: this is the first and only similar complaint received on product code # 9055. 51. 035, involving the breakage of the impact surface, on a total of (b)(4) devices manufactured with this product code. No corrective actions planned at the moment. Limacorporate will keep monitored the market to promptly detect a possible recurrence of such issue.
 
Event Description
Intra-operative breakage of the impact surface of the delta cup curved impactor (model #9055. 51. 035, lot# 201402086) during cup impaction. No reported consequences for the patient. No prolonged surgery time. Event occurred in (b)(6).
 
Manufacturer Narrative
The check of the dhr of the lot # involved did not show any pre-existing anomaly on the 11 pieces of delta cup curved impactor (code #9055. 51. 035) manufactured with lot #201402401. This is the first and only complaint received on this lot #. We will submit a final mdr once we complete our investigation.
 
Event Description
Intra-operative breakage of the impact surface of the delta cup curved impactor (model # 9055. 51. 035) during cup impaction. No reported consequences for the patient. No prolonged surgery time. Event occurred in (b)(6).
 
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Brand NameDELTA CURVED IMPACTOR
Type of DeviceCURVED IMPACTOR
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale,52
villanova di san daniele, 33038
IT 33038
Manufacturer (Section G)
LIMACORPORATE S.P.A.
via nazionale,52
villanova di san daniele, 33038
IT 33038
Manufacturer Contact
giulio puppa
via nazionale 52
villanova di san daniele 
MDR Report Key6713289
MDR Text Key256561546
Report Number3008021110-2016-00109
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K112898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9055.51.035
Device Lot Number201402401
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/27/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/20/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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