MAUDE Adverse Event Report: LIMACORPORATE SPA SMR GLENOID REAMER SMALL; KWT, HSD

Model Number 9013.75.160

Device Problem Dull, Blunt (2407)

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

Event Date 08/17/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (14aa342) showed no dimensional / functional anomalies on the 54 pieces placed on the market with this lot #.We will submit a final mdr after completing the investigation on this case.

Event Description

The reamer for glenoid bone was found to be blunt during a shoulder replacement surgery performed on the (b)(6) 2016.Reaming time was slightly prolonged due to this.No reported consequences for the patient.Event occurred in (b)(6).

Event Description

The reamer for glenoid bone was found to be blunt, during a shoulder replacement surgery performed on the (b)(6) 2016.Reaming time was slightly prolonged due to this issue.No reported consequences for the patient and surgeon happy with final result.Event occurred in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot # involved (14aa342) showed no dimensional / functional anomalies on a total of 54 small reamers placed on the market with the same lot#.The affected instrument was received by limacorporate.A visual analysis of the reamer confirmed that the reamer cutting edge is blunt.The number of uses of the instrument before the occurrence of the issue is unknown (the instrument was manufactured in february 2015).Likely cause for the reamer to be blunt was identified as the combination of bead blasted cutting edge and chrome coating applied on the reamer.In fact, bead blasting and chrome coating applied to the cutting edge may reduce the edge sharpness and the reamer may results to be blunt.In september 2015, before receiving this complaint, limacorporate updated the technical drawings of the reamers to clearly specify that bead blasting and chrome coating must not be applied on the cutting edge of the reamers with product code 9013.75.160-165-170.The reamer involved in this complaint was manufactured in 2014, before introduction of this note in the technical drawing.Pms data: a total of (b)(4) similar cases have been reported to limacorporate on blunt glenoid reamers with model # 9013.75.160-165-170.(b)(4).No further action planned for this specific case, considering the drawing update performed in september 2015.Limacorporate will continue monitoring the market in order to promptly detect any similar issue.

• Brand Name: SMR GLENOID REAMER SMALL
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 6666624
• MDR Text Key: 78589754
• Report Number: 3008021110-2016-00097
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.75.160
• Device Lot Number: 2014AA342
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization