MAUDE Adverse Event Report: LIMACORPORATE SPA SMR - REVERSE PROSTHESIS INSERTER

Model Number 9013.52.142

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

We will send a final mdr once the investigation will be completed.

Event Description

During a shoulder revision surgery performed on (b)(6) 2018, while impacting definitive revision stem and humeral body, the threaded tip of the reverse prosthesis inserter broke.The inserter body fell to the floor while the threaded tip remained wedged into the implanted humeral body.According to the info reported, the sudden breakage of the threaded tip has also led to an incorrect alignment of the humeral body.As a consequence, surgeon had to remove the humeral body already implanted to correctly reposition it.Moreover, a forcep was used to extract the threaded tip from the humeral body.No consequences for the patient; 4 minutes of prolonged surgery time were reported due to this issue.Event happened in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot involved (14aa285) didn't show any pre-existing anomaly on the 12 smr reverse prosthesis introducers manufactured with this lot #.No other complaint received on this lot #.We received instrument's pictures clearly showing the threaded tip breakage experienced.With no instrument in our hand, no deep analysis can be done to discover the root cause for the breakage.At this stage, we can speculate that a possible cause for the thread breakage could have been an improper use of the instrument during the impaction of the reverse humeral body.As the instrument involved was manufactured in 2014, it is also possible that the instrument thread was slightly (not visibly) damaged before this specific surgery.Manufacturing records were checked and the batch was manufactured correctly up to specs and in-line with the relevant checks and tests and no manufacturing deviations were reported.This is not a product-related case.Pms data: this is the only tip breakage case reported on a reverse humeral body introducer (model # 9013.52.142) on a total of 454 smr reverse prosthesis introducers manufactured, giving a specific breakage rate of (b)(4).No corrective action has been planned for this specific event.Limacorporate will keep monitoring the market on the reoccurrence of this event.

Event Description

During a shoulder revision surgery performed on (b)(6) 2018, while impacting definitive revision stem and humeral body, the threaded tip of a reverse prosthesis inserter code 9013.52.142, lot# 14aa285 broke.According to the info reported, the inserter body fell to the floor while the threaded tip remained wedged into the implanted humeral body.The sudden breakage of the threaded tip led to an incorrect alignment of the humeral body so that surgeon had to remove the humeral body already implanted to correctly reposition it.A force was then used to extract the threaded tip from the humeral body.No consequences for the patient; 4 minutes of prolonged surgery time were reported due to this issue.Estimated number of uses of the instrument: unknown.Event occurred in (b)(6).

• Brand Name: SMR - REVERSE PROSTHESIS INSERTER
• Type of Device: SMR - REVERSE PROSTHESIS INSERTER
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 7326441
• MDR Text Key: 102119560
• Report Number: 3008021110-2018-00015
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K110598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.52.142
• Device Lot Number: 14AA285
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization