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 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (#14aa458) did not show any anomaly on the (b)(4) smr resection jigs manufactured with this lot #.We will submit a final report once the investigation will be completed.

Event Description

Intra-operative issue occurred on the (b)(6) 2019 during a total reverse shoulder replacement.The surgeon was drilling in a 3mm steinmann pin through the reverse resection jig (smr -reverse resection jig dpa, code #9013.52.304, lot #14aa458) to secure it, when the wire became stuck.Event occurred in (b)(6).

Manufacturer Narrative

Check of the dhr: the check of the manufacturing charts of the lot# involved did not show any anomaly on the 56 smr reverse resection jigs manufactured with this lot#.Instrument analysis: reverse resection jig involved was received for investigation together with the competitor's pin still stuck into the hole.The competitor's pin was removed by the resection jig and a dimensional analysis on the jig holes was performed.All the hole diameters were found to be compliant to drawing specification (3.05÷3.10mm).External surface of the competitor's pin was visibly worn on both the tip the body: this could have contributed to the pin getting stuck into the jig.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-op risk of seizure of the pin into the jig holes.Lot numbers of the resection jigs involved in this and in all the previous similar complaints reported were manufactured before the drawing improvement.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 a total reverse shoulder replacement.The surgeon was drilling in a 3mm steinmann pin through the lima reverse resection jig (smr reverse resection jig with code #9013.52.304, lot #14aa458) to secure it, when the wire became stuck.Eventually, less than 3 minutes of prolonged surgery time experienced due to this issue: surgeon resected the humeral head without guide.No consequences for the patient reported.Surgeon was happy with the final stability of the prosthesis implanted.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: 8411353
• MDR Text Key: 139438288
• Report Number: 3008021110-2019-00027
• 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: 07/26/2019

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: 14AA458
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization