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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR REVERSE RESECTION JIG
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LIMACORPORATE S.P.A. SMR REVERSE RESECTION JIG Back to Search Results
Model Number 9013.52.304
Device Problem Entrapment of Device (1212)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The check of the dhr of the lot # involved (lot #2015aa037) did not show any anomalies on the (b)(4) pieces manufactured with this lot#, thus indicating that the devices were compliant to specifications when they were released on the market.We will submit a final mdr once our investigation is concluded.
 
Event Description
Intra-operative issue involving a smr reverse resection jig (code # 9013.52.304): after the resection of the humeral head, it was noticed that the pin got stuck inside the resection jig.The devices were pulled out in one piece.No reported consequences for the patient.Event occurred in (b)(6).
 
Event Description
Intra-operative issue involving a smr reverse resection jig (code # 9013.52.304, lot# 15aa037): after the resection of the humeral head, it was noticed that the pin got stuck inside the resection jig.The devices were pulled out in one piece.No reported consequences for the patient.Event occurred in (b)(6).
 
Manufacturer Narrative
The check of the dhr of the lot # involved (lot #2015aa037) did not show any anomalies on the (b)(4) pieces manufactured with this lot#, thus indicating that the devices were compliant to specifications when they were released on the market.We received the reverse resection jig and the lima pin involved in the intra-op issue: as model# and lot# are not marked on the pin, and the complaint source could not provide model# and lot# of the pin, we could not check its manufacturing chart.By a visual check, the external surface of the pin is very damaged and rough, probably due to repeated (and maybe inaccurate) use of the pin.External surface appears to be not perfectly circular.A functional check with the returned devices confirmed that, due to damage and slight deformation of the pin, the pin cannot pass through some of the holes of the resection jig.A dimensional check was also performed on the devices returned with following results: male diameter of the pin: slight over-dimensioning measured at its central part (where it was more worn out); female diameters (holes) of the jig: on the left side 6 out of 7 holes of the jig were found to be compliant to drawing specifications, while the 7th had a slight under-dimensioning; on the right side 5 out of 7 holes were found to be compliant to drawing specification, while 2 of them had a slight under-dimensioning.According to the complaint source, the pin stuck in one of these 2 non compliant holes on the right side; the mix of slight over-dimensioning of the central part revealed on the pin and the under-dimensioning of the holes on the right side is then the likely cause for the intra-op seizure reported.In may 2016, the technical drawing of the smr reverse resection jig was modified in order to slightly increase the holes diameter and reduce the risk of intra-op seizure of the pin into the holes.Pms data: limacorporate is aware of a total of (b)(4) similar events with resection jigs model # 9013.52.304.For the cases where we received and could analyze the devices involved, the cause of the seizure between jig and pin was identified to be the damage on the external surface of the pin (male taper), maybe due to its improper use, combined with the dimensions of the pin diameter very near to the maximum allowed or slightly exceeding the maximum allowed (after damaging).For some of the cases where we received all the info, a pin from another manufactures was used in combination with the lima resection jig.The reverse resection jigs involved in all the 15 cases reported were manufactured before the technical improvement on the holes diameter.No complaints have been reported on the improved resection jigs.Limacorporate will continue to monitor the market to promptly detect the possible recurrence of this issue and assess the effectiveness of the corrective action performed.
 
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Brand Name
SMR REVERSE RESECTION JIG
Type of Device
SMR REVERSE RESECTION JIG
Manufacturer (Section D)
LIMACORPORATE S.P.A.
via nazionale 52
villanova di san daniele, 33038
IT  33038
MDR Report Key6713583
MDR Text Key80284707
Report Number3008021110-2016-00114
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
PMA/PMN Number
K100858
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model Number9013.52.304
Device Lot Number2015AA037
Was the Report Sent to FDA? No
Date Manufacturer Received11/08/2016
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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