MAUDE Adverse Event Report: LIMACORPORATE SPA SMR -REVERSE RESECTION JIG DPA; SMR -REVERSE RESECTION JIG DPA (KWT, HSD)

Model Number 9013.52.304

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

A check of the manufacturing charts of the lot involved (#16ab04q) has been made.By checking the manufacturing charts of this lot #, no anomaly was detected on the products placed on the market, meaning that they had no pre-existing anomaly.No other complaint received on this lot #.We will proceed with further investigations and submit a final report once concluded.

Event Description

During primary smr reverse surgery (date: (b)(6) 2019), the pin got stuck in the reverse resection jig (code # 9013.52.304, lot # 16ab04q) and the surgeon was not able to disengage the two instruments.Consequently, the surgeon decided to hammer the pin on to proceed with cutting the humeral head.This issue prolonged the surgery by 2-3 minutes.Event happened in (b)(6).

Manufacturer Narrative

Check of the dhr: the check of the manufacturing charts of the lot # involved did not show any anomaly on the 54 smr reverse resection jigs manufactured with this lot #.Instrument analysis: smr reverse resection jig involved was received for investigation together with the lima pin still stuck into the hole.The pin was removed and a dimensional analysis on the jig's holes was performed.All the hole diameters were found to be compliant to drawing specification (3.05÷3.10mm).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 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); these conditions could have contributed the pin getting stuck into the jig.Corrective actions: 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.Pms data: according to our pms data and considering the resection jigs code 9013.50.304 and 9013.52.304-305 manufactured prior drawing improvement, the occurrence rate of this kind of event is 1.44%.Since the new design has been introduced, only one case has happened with an occurrence rate of 0.16%.Both these occurrence rates are overestimated because they do not consider the reuse of the instrument.Most of these issues happened after several uses of the resection jigs or of the pins.None of these cases had serious consequences on the patient or prolonged surgical time.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

During a smr reverse surgery performed on (b)(6) 2019, the lima pin got stuck in a smr reverse resection jig with product code 9013.52.304 and lot #16ab04q.Since the surgeon was not able to disengage the two instruments, it was decided to hammer the pin on to proceed with cutting the humeral head.According to the info reported, only 2 or 3 minutes of prolonged surgery time was experienced due to this issue.Event happened in new zealand.

• Brand Name: SMR -REVERSE RESECTION JIG DPA
• Type of Device: SMR -REVERSE RESECTION JIG DPA (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8373799
• MDR Text Key: 139211788
• Report Number: 3008021110-2019-00020
• 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
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.52.304
• Device Lot Number: 16AB04Q
• Date Manufacturer Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization