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

Model Number 9013.52.304

Device Problem Mechanical Jam (2983)

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

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the lot# involved, no anomaly was found.This is the first and only complaint received on this lot#.We will submit a final mdr once the investigation will be concluded.

Event Description

Intra-operative issue occurred on (b)(6) 2019.During surgery, the pin (9066.15.095, lot#1408792) got stuck in the smr reverse resection jig 9013.52.304 lot#15aa989.Another pin guidance was used.The event did not lead to prolonged surgery.Event occured in (b)(6).

Event Description

Intra-operative issue occurred on (b)(6) 2019.During surgery, the pin (9066.15.095 lot#1408792) got stuck in the smr reverse resection jig 9013.52.304 lot#15aa989.The event did not lead to prolonged surgery time.According to the information received, the surgery was positively completed with another available instrument.The affected instrument was used more that 40 times.Event happened in austria.

Manufacturer Narrative

By checking the manufacturing charts of the lot#s involved (jig lot#15aa989, pin lot# 1408792), no pre-existing anomaly was found on the products placed on the market with the same lot#s.This is the first and only complaint received on these lot#s.The instruments involved in this intra-operative incident (resection jig and pin) were returned to limacorporate for technical investigation.As the pin is jammed into the resection jig hole, the two instruments cannot be safely disengaged by a lima operator, thus no deeper analysis of the jig hole is possible.Based on the analysis performed over time on similar complaints, damaged external surface of the pin can strongly contribute to the seizure.We can therefore speculate that a damage due to the repeated (and maybe inaccurate) use of the pin over time could have contributed to this event.Without a dimensional analysis of the jig hole, we cannot establish if in this specific case the hole dimensions are within the tolerances.To reduce the risk of recurrence of these kind of events, in may 2016 the technical drawing of the resection jigs (codes 9013.50.304 and 9013.52.304-305) 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.The resection jig involved in this complaint was manufactured before the design improvement.According to our pms data, the occurrence rate of this kind of issue is (b)(4) (estimated as number of similar complaints received on the total number of resection jigs codes 9013.50.304 and 9013.52.304-305 manufactured).Only one similar case happened with the improved version of the jigs (manufactured after the drawing adjustment introduced in 2016), meaning an occurrence rate for the improved drawing of (b)(4).Both these occurrence rates are overestimated because they do not consider the reuse of the instruments.Most of these issues happened after several uses of the resection jigs or of the pins.None of these cases had serious consequences for the patient.Limacorporate will continue monitoring the market to promptly detect any further similar issue and confirm the effectiveness of the corrective action performed.

• Brand Name: SMR REVERSE RESECTION JIG
• Type of Device: SMR REVERSE RESECTION JIG (KWT, HSD)
• Manufacturer (Section D): LIMAORPORATE SPA; via nazionale 52; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9415922
• MDR Text Key: 219386587
• Report Number: 3008021110-2019-00142
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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: 15AA989
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization