MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR -REVERSE RESECTION JIG; REVERSE RESECTION JIG (KWT, HSD)

Model Number 9013.52.304

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

The check of the manufacturing chart did not show any anomaly on a total of 90 reverse resection jig manufactured with lot# 2015aq01c.We will send a final emdr once the evaluation will be concluded.

Event Description

While surgeon was preparing for cutting the humeral head, a lima pin got stuck in the reverse resection jig.According to the info reported, the pin stuck before making contact with bone, so surgeon was able to continue the surgery without extending the surgical time.No consequences for the patient reported.Surgeon was happy with the final surgery outcome.Estimated number of uses of the instrument unknown.Event happened in australia on (b)(6) 2018.

Manufacturer Narrative

Dhr check: the check of the manufacturing chart did not show any anomaly on a total of 90 reverse resection jig manufactured with lot# 2015aq01c.We did not receive the information on the lot# of the pin, thus the dhr check of the pin is not possible.Instrument's analysis: reverse resection jig involved in this intra-operative issue was returned to limacorporate.A dimensional check was performed on the female diameters (holes) of the reverse resection jig with the following results: - on the left side (faulty side, according to complaint source), 7 out of the 7 holes of the jig were found to be compliant to drawing specifications (3.05÷3.10mm).- on the right side, 6 out of the 7 holes of the jig were found to be compliant to drawing specification (3.05÷3.10mm), while the 7th resulted to be slightly under-dimensioned (actual dia.3.014mm).Lima pin involved was not returned to limacorporate so we could not performing a dimensional check nor an accurate visual inspection of the pin by observing its external surface.We only received a picture of the involved pin from which we cannot take appropriate consideration about pin status since it was not completely visible but stuck inside the resection jig.According to previous similar cases received and analysed, in case of worn/damaged pins (due to repeated and maybe inaccurate use of the pins themselves), the conditions of their external surfaces can make difficult for the pins to pass through the hole, causing the seizure of the pin into the jig's hole.Conclusion: based on the missing (pin not returned) and available info and on the analysis performed, we can reasonably speculate that a combination of the worn surface of the reusable pin and the slight under-dimensioning found on the corresponding hole on the right side (no anomalies found on the left side complained) could have contributed to the seizure.No corrective action for this specific case.After receiving previous similar complaints, in may 2016 the technical drawing of the smr reverse resection jig was adjusted to slightly increase the holes diameter of the jig and therefore further reduce the intra-op risk of seizure of the pin into the jig holes.Lot numbers of the resection jigs involved in this and in all the previous similar complaints reported were manufactured before the drawing improvement.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.

Event Description

Intra-op issue occurred on (b)(6) 2018: while surgeon was preparing for cutting the humeral head, a lima pin got stuck in the left bottom hole of the reverse resection jig (code 9013.52.304, lot# 15aq01c).According to the info reported, the pin got stuck before making contact with bone, so surgeon was able to continue the surgery using another pin hole, without extending the surgical time.No consequences reported for the patient.Surgeon was happy with the final surgery outcome.Estimated number of uses of both the pin and the resection jig is unknown.Event happened in australia.

• Brand Name: SMR -REVERSE RESECTION JIG
• Type of Device: REVERSE RESECTION JIG (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 7250748
• MDR Text Key: 100175141
• Report Number: 3008021110-2018-00003
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.52.304
• Device Lot Number: 2015AQ01C
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1