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

Model Number 9013.52.304

Device Problem Entrapment of Device (1212)

Patient Problem No Code Available (3191)

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 #14aa458.According to the information reported, the pin was manufactured by limacorporate.Consequently, the surgeon performed the humeral cut by freehand.The event prolonged the surgery of 3 minutes.Event occurred in (b)(6).

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 #14aa458.Consequently, the surgeon performed the humeral cut by freehand.According to the information reported, the pin (code and lot# unknown) was manufactured by limacorporate.The event prolonged the surgery of 3 minutes.Event happened in australia.

Manufacturer Narrative

Check of the dhr: by checking the dhr of the lot #14aa458, no pre-existing anomaly was detected on 56 smr-reverse resection jigs manufactured.Therefore, all the items were up to specifications.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 5 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, (b)(4).Since the new design has been introduced, (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 DPA
• Type of Device: SMR -REVERSE RESECTION JIG DPA (KWT, HSD )
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 9179933
• MDR Text Key: 194472278
• Report Number: 3008021110-2019-00115
• 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: 04/01/2020

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: 14AA458
• Date Manufacturer Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention