MAUDE Adverse Event Report: LIMACORPORATE SPA NSERTER-EXTRACTOR HANDLE SMR; NSERTER-EXTRACTOR HANDLE SMR (KWT, HSD)

Model Number 9013.02.304

Device Problems Loose or Intermittent Connection (1371); Physical Resistance/Sticking (4012)

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

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing charts of the involved lot#s, no pre - existing anomalies were found on the instruments placed on the market.We will submit a final report once the investigation will be concluded.

Event Description

Intra-operative issue occurred on (b)(6) 2019 during a smr total anatomic replacement.When the surgeon attached the inserter-extractor handle (code #9013.02.304, lot #17ae00t) to the humeral body and stem, the handle became stuck, and the middle rod had to be adjusted for it to become unstuck.Furthermore, after closing the handle, it became loose and flimsy.It is reported that the incident happened with both the instruments available in the set.Surgery was prolonged of 10 minutes.Event occurred in (b)(6).

Event Description

Intra-operative issue occurred during a smr total anatomic replacement on march 12, 2019.When the surgeon attached the inserter-extractor handle (code #9013.02.304, lot #17ae00t) to the humeral body and stem, the handle became stuck, and the middle rod had to be adjusted for it to become unstuck.Furthermore, after closing the handle, it became loose and flimsy.It is reported that the incident happened with both the 2x handles available in the set and surgeon was able to complete the surgery using a screwdriver and the old impactor.Surgery was prolonged of 10 minutes.Estimated number of uses of the instrument unknown.Event occurred in new zealand.

Manufacturer Narrative

Check of the dhr: by checking the dhrs of the involved instruments lot, no pre - existing anomaly was found on a total of 20 inserter-extractor handles manufactured with this lot#.Instrument analysis: instruments not available to be returned to lima corporate: without having the possibility to analyze the handles involved a deeper analysis is not possible.Conclusion stating that: no instruments available to be analyzed; no possibility to perform a dimensional checks nor functional test; estimated number of uses of the instrument is unknown; no pictures of the instruments available; no product info about implantable components were provided; we cannot estimate a certain root cause for the issue experienced.Furthermore, we did not receive code and lot# of the humeral body and of the adaptor sleeve either, which are connected to the impactor-extractor during procedure and could be responsible of this issue.Based on the check of the dhrs we can speculate that event cannot be classified as products-related.Pms data we are aware of a total of 5 similar intra-operative issues (including the current one) on a total of 268 9013.02.304 inserter-extractors manufactured.All the events were judged as not product related.No specific action for this case, limacorporate will continue monitoring the market to promptly detect any further similar event.

• Brand Name: NSERTER-EXTRACTOR HANDLE SMR
• Type of Device: NSERTER-EXTRACTOR HANDLE SMR (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8508921
• MDR Text Key: 149796280
• Report Number: 3008021110-2019-00113
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.02.304
• Device Lot Number: 17AE00T
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization