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

Model Number 9013.52.165

Device Problems Output Problem (3005); Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

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

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the involved lot numbers, no anomaly was found.This is the first and only complaint received on these lot numbers and codes.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-operative issue occurred on (b)(6) 2019.During surgery, extraction instruments for reverse body malfunctioned and failed to dissociate reverse humeral body from the stem.The event prolonged the surgery of 15 minutes.The instruments involved are the following: 9013.50.175, smr - univer.Stem f.Extractor, lot #14aa136.9013.52.165, smr - expansion extractor, lot #14aa416.According to the info reported, it is not clear which instrument did not work correctly.Surgeon completed the surgery using the instruments from the anatomical smr tray.Event occurred in (b)(6).

Event Description

Intra-operative issue occurred on (b)(6) 2019.During surgery, extraction instruments for reverse body malfunctioned and failed to dissociate reverse humeral body from the stem.The event prolonged the surgery of 15 minutes.The following instruments were involved: 9013.50.175, smr - univer.Stem extractor, lot #:14aa136; 9013.52.165 smr - expansion extractor lot #:14aa416.According to the info reported, it is not clear which instrument did not work correctly.Surgeon completed the surgery using the instruments from the anatomical smr tray.Event occurred in australia.

Manufacturer Narrative

By checking the dhrs of the involved lots, no anomaly was found.On a total of (b)(4)expansion extractors manufactured with lot #14aa416.On a total of (b)(4) stem extractors manufactured with lot #14aa136.We requested the instruments to be returned for analysis, but they were not sent to us.At this stage, we are not able to investigate deeply the root cause of the event.On the basis of the check of the manufacturing chart, we can judge this event as not product related.Pms data: (b)(4).Please note that occurence rate is highly overestimated since it is not possible to take into account the number of usage of these instruments (re-usable components).No corrective actions planned for this specific case.Lima corporate will keep the market monitored.

• Brand Name: SMR - EXPANSION EXTRACTOR
• Type of Device: SMR - EXPANSION EXTRACTOR (KWT, HSD)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 8788219
• MDR Text Key: 200417224
• Report Number: 3008021110-2019-00079
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9013.52.165
• Device Lot Number: 14AA416
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization