MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR: INSERTER EXTRACTOR HANDLE; INSERTER-EXTRACTOR HANDLE

Model Number 9013.02.304

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

By checking the dhr of the lot# 19bg06b, no pre-existing anomalies were detected on all the components manufactured with this lot #.This is the first and only complaint received on this lot number.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-operative event occurred during a shoulder replacement performed on (b)(6) 2020.While inserting the trial stem and proximal reamer guide, the purple line marker of the inserter extractor handle (product code 9013.02.304, lot# 19bg06b) fell off the instrument into the patient.The plastic marker was easily removed from the surgical site and the surgery was completed as per surgical technique with no consequences for the patient nor prolonged surgery time.Event happened in (b)(6).

Event Description

Intra-operative event occurred during a shoulder replacement performed on (b)(6) 2020.While inserting the trial stem and proximal reamer guide, the purple line marker of the inserter extractor handle (product code 9013.02.304, lot# 19bg06b) fell off the instrument into the patient.The plastic marker was easily removed from the surgical site and the surgery was completed as per surgical technique, with no consequences for the patient nor prolonged surgery time.Estimated number of uses of the instrument: 15 times.Event happened in australia.

Manufacturer Narrative

By checking the dhr of the lot# 19bg06b, no pre-existing anomalies were detected on all the components manufactured with this lot #.This is the first and only complaint received on this lot number.The instrument was not available to be returned to limacorporate for further analysis.We received a picture of the instrument where it was clearly visible the detachment of the purple line marker.An evaluation of product improvement is currently ongoing.At this stage, no evidence available for classifying the event as product related.Pms data: according to our pms data, we are currently aware of two similar events.We will then evaluate if any specific corrective action is needed.Limacorporate will continue monitoring the market to promptly detect any future similar issue.Note: this is a final mdr.

• Brand Name: SMR: INSERTER EXTRACTOR HANDLE
• Type of Device: INSERTER-EXTRACTOR HANDLE
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 10459078
• MDR Text Key: 207389612
• Report Number: 3008021110-2020-00062
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 19BG06B
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other