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 Physical Resistance/Sticking (4012)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturer chart of the lot involved (#17aq0vfa), no anomaly was found.This is the first and only complaint received on this lot#.We will provide a final report once the investigation will be concluded.

Event Description

Intra-operative issue occurred on (b)(6) 2019 during a total reverse shoulder replacement.While surgeon was drilling 3mm k-wire through reverse resection jig to secure into patient's humeral head, k-wires got stuck into the resection jig holes (code #9013.52.304, lot #17aq0vfa).The incident prolonged surgery less than 2 minutes.Event occurred in (b)(6).

Manufacturer Narrative

Check on the dhr.By checking the manufacturer chart of the lot #17aq0vf, no pre-existing anomaly was found on 32 smr-reverse resection jigs manufactured.This is the first and only complaint received on this lot#.Instrument analysis: pictures of the instrument show the k-wire stuck in the hole of the reverse resection jig.However, the instrument was not returned to limacorporate, therefore it was not possible to perform any technical investigation.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.No further similar complaints were received on instruments manufactured after the implementation of this drawing change.On the basis of the information received, we are not able to investigate the root cause of the incident.However, considering that all the instruments manufactured with lot # 17aq0vf were up to specifications and no other complaints were received on the same lot#, we cannot judge this incident as product related.Pms data: according to our pms data and considering the resection jigs code 9013.50.304 and 9013.52.304-305 manufactured after drawing improvement, the occurrence rate of this kind of event is 0.15%.This occurrence rates is overestimated because it does not consider the reuse of the instrument.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 the (b)(6) 2019 during a total reverse shoulder replacement.While surgeon was drilling 3mm k-wire through reverse resection jig to secure into patient's humeral head, k-wires got stuck into the resection jig holes (code #9013.52.304, lot #17aq0vf).Surgeon was performing deltopectoral approach.According to the information reported, surgeon inserted second k-wire and proceeded to resect humeral head as per surgical technique.Surgeon pulled out the second k-wire with pliers and then used the pliers on the resection jig to remove it and the broken kwire off the patient.The incident prolonged surgery less than 2 minutes.Event occurred in australia.

• 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: 8411351
• MDR Text Key: 139211219
• Report Number: 3008021110-2019-00026
• 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: 03/12/2019
• 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: 17AQ0VF
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization