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

Model Number 9013.52.304

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Failure of Implant (1924)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

By the check of the dhrs, no pre- existing anomaly was found on the products placed on the market with lot# 15aq01c.We will provide the final mdr as soon as our investigation will be concluded.

Event Description

Intra-operative issue experienced with the reverse resection jig code 9013.52.304, lot# 15aq01c: the pin was inserted into one of the resection jig holes and got stuck.As a consequence, the pin broke while triyng to remove it with a driver.The issue occurred in (b)(6) on (b)(6) 2020 and caused 5 minutes of prolonged surgery time.

Manufacturer Narrative

Check of the dhr: by the check of the dhr, no pre- existing anomaly was found on the 90 products placed on the market with lot# 15aq01c.Code and lot# of the pin were not provided by the complaint source.Instrument analysis: the instruments involved in the incident were not returned to limacorporate for technical investigation.A picture provided by the complaint source, shows the pin jammed into the reverse resection jig, and part of the end of the pin broke.From the picture, it was not possible to perform any kind of investigation.Based on the information received, we cannot investigate the root cause of the incident.However, considering that the instrument was 4 years old when the incident occurred and considering the presence of similar complaints on the same instrument code, we can hypothesize that the event was due to a combination of wear due to usage, design factors and surgical factors.However, 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-operative 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 2.12%.Since the new design has been introduced, only one case has happened with an occurrence rate of 0.15%.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 caused 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

Intra-operative issue experienced with the reverse resection jig code 9013.52.304, lot# 15aq01c.The pin was inserted into one of the resection jig hole and got stuck.As a consequence, the pin broke while triyng to remove it with a driver.Furthermore, surgeon was unable to use that hole of the resection jig as desired to secure pin to humerus.The issue occurred on (b)(6) 2020 and caused 5 minutes of prolonged surgery time.Estimate number of usage of the instrument is unknown.No consequence for the patient.Event occurred in (b)(6).

• Brand Name: SMR -REVERSE RESECTION JIG DPA
• Type of Device: REVERSE RESECTION JIG - DELTOPECTORAL APPROACH (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9611202
• MDR Text Key: 221026982
• Report Number: 3008021110-2020-00003
• 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
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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: 15AQ01C
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization