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

Model Number 9013.52.304

Device Problems Positioning Failure (1158); Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

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

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot #15aa037, no anomaly was found.We will submit a final report once the investigation will be completed.

Event Description

Intra-operative issue occurred on the (b)(6) 2019.During surgery, a pin got stuck into the secure reverse resection jig code (b)(4), lot #15aa037 and could not be moved to gain desired insertion into the humeral bone.Surgeon completed the surgery using only one pin and the surgery was prolonged of 5 minutes.Event occurred in (b)(6).

Event Description

Intra-operative issue occurred on the (b)(6) 2019.During surgery, a pin got stuck into the secure reverse resection jig code 9013.52.304 lot #15aa037 and could not be moved to gain desired insertion into the humeral bone.Surgeon completed the surgery using only one pin and the surgery was prolonged of 5 minutes.Event occurred in (b)(6).

Manufacturer Narrative

Check oh dhr: by checking the manufacturing chart of the lot #15aa037, no pre-existing anomaly was found on 41 smr -reverse resection jig manufactured.Instrument analysis: the instruments involved in the intra-operative incident (resection jig and pin) were not returned to limacorporate for technical investigation.Pictures were also not available for a visual inspection of instrument condition.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 factor and surgical factor.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 (b)(4).Since the new design has been introduced, only one case has happened with an occurrence rate of (b)(4).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.

• 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: 8964011
• MDR Text Key: 194343605
• Report Number: 3008021110-2019-00095
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• 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: 15AA037
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization