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

Model Number 9013.52.304

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #, no anomaly was found.We will submit a final mdr once the investigation will be concluded.

Event Description

Intra-operative issue occurred on (b)(6) 2019.During smr primary surgery the pin got stuck into the smr -reverse resection jig code (b)(4), lot #15aa037 and broke in half.No other information were reported by the complaint source.Event occurred in (b)(6).

Manufacturer Narrative

Check of the dhr: by checking the dhr of the lot #15aa037, no pre-existing anomaly was detected on 41 smr -reverse resection jigs manufactured.Instrument analysis: the instruments involved in the intra-operative incident (resection jig and pin) were not returned to limacorporate for technical investigation.Picture of the instrument shows the pin jammed into the resection jig.However, based on the provided picture, it is not possible to do any spaculation on the root cause of the event.Based on the few 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 factor and surgical factor.Corrective action has already been implemented on family of code 9013.52.304/305.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 occurred on (b)(6) /2019.During smr primary surgery the pin got stuck into the smr -reverse resection jig code 9013.52.304 lot #15aa037 and broke in half.The event did not cause any adverse effect on the patient and the surgery was prolonged of 2-3 minutes.No other information were reported by the complaint source.Event happened in australia.

• Brand Name: SMR -REVERSE RESECTION JIG
• Type of Device: SMR -REVERSE RESECTION JIG (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9179080
• MDR Text Key: 194512423
• Report Number: 3008021110-2019-00116
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 15AA037
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization