MAUDE Adverse Event Report: LIMACORPORATE S.P.A. GLENOID REAMER SMALL

Model Number 9013.75.160

Device Problem Dull, Blunt (2407)

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

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (14aa342) showed no dimensional / functional anomalies on the (b)(4) pieces placed on the market with this lot #.We will submit a final mdr after completing the investigation on this case.

Event Description

Intra-operative issue involving a small smr-glenoid reamer (model # 9013.75.160, lot # 14aa342).Surgeon was using the small reamer when he noticed that it was blunt.The reamer was attached to drill at the time of surgery.Minimal extension of surgical time (3 minutes).The surgery was successfully completed by the surgeon using a standard reamer.No adverse effect on patient.Event occurred in (b)(6).

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 #.The involved instrument was received by limacorporate.Visual analysis of the reamer confirmed that the reamer cutting edge is blunt.A technical analysis of the device highlighted that the cutting edge was bead blasted and chrome coating was applied on it.Bead blasting and chrome coating applied to the cutting edge reduce the edge sharpness and the reamer results blunt.In september 2015, before receiving this complaint, limacorporate updated the technical drawings of the reamers to 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 5 similar cases have been reported to limacorporate on blunt glenoid reamers with product codes 9013.75.160-165-170 on a total of (b)(4) reamers manufactured.No corrective action planned for this specific case.Limacorporate will continue monitoring the market in order to promptly detect any similar issue.

Event Description

Intra-operative issue involving a small smr-glenoid reamer (model # 9013.75.160, lot # 14aa342).Surgeon was using the small reamer when he noticed that it was blunt.The reamer was attached to drill at the time of surgery.Minimal extension of surgical time (3 minutes).The surgery was successfully completed by the surgeon using a standard reamer.No adverse effect on patient.Event occurred in (b)(6).

• Brand Name: GLENOID REAMER SMALL
• Type of Device: GLENOID REAMER SMALL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale, 52; villanova di san daniele, 33038 ; IT 33038 ; 2 945511
• MDR Report Key: 6173192
• MDR Text Key: 62692644
• Report Number: 3008021110-2016-00050
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1