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 Type  malfunction  

Manufacturer Narrative

The reamer for glenoid bone was found to be blunt during a shoulder replacement surgery done on (b)(6) 2017.Reaming time was slightly prolonged due to this issue (5-10 minutes).No consequences reported 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 done on (b)(6) 2017.Reaming time was slightly prolonged due to this issue (5-10 minutes).No consequences reported for the patient.Event occurred in (b)(6).

Manufacturer Narrative

The check of the dhr of the lot # involved (2014aa342) 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.This lot# is available on the market since february 2015, and the issue occurred in may 2017.The number of uses of the instrument before the occurrence of the issue is unknown.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 therefore 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 model# 9013.75.160-165-170.This note was already present in the original version of the drawing, but it has been "highlighted" in the updated version of the drawing.The reamer involved in this complaint was manufactured before the drawing update (in february 2015).Pms data: a total of 5 similar cases have been reported to limacorporate on blunt glenoid reamers with model # 9013.75.160-165-170.As the estimated number of ww uses of these reusable instruments is 9.250, the occurrence rate results to be 0.054%.No corrective action planned for this specific case, considering the drawing update performed in september 2015.No similar complaints have been received for glenoid reamers manufactured according to the updated drawing.Moreover, the external supplier (orchid) of the lot# 2014aa342 involved in this case is no more a lima supplier.Limacorporate will continue monitoring the market in order to promptly detect any similar issue, and confirm the effectiveness of the improvements introduced.

Event Description

The reamer for glenoid bone was found to be blunt during a shoulder replacement surgery done on (b)(6) 2017.Reaming time was slightly prolonged due to this issue (5-10 minutes).No consequences reported for the patient.Event occurred in australia.

• 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: 6688851
• MDR Text Key: 79279725
• Report Number: 3008021110-2017-00050
• 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

• Date FDA Received: 07/06/2017
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization