MAUDE Adverse Event Report: LIMACORPORATE S.P.A HELIX DRILL D. 3.5MM

Model Number 9084.20.081

Device Problem Material Fragmentation (1261)

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

Event Date 05/03/2016

Event Type  malfunction  

Manufacturer Narrative

Dhr: the check of the dhr of the lot # involved (201413691) did not show any pre-existing anomaly on the 50 helix drill manufactured with this lot #.Instrument analysis: we did not receive the instrument back to lima corporate hq, so we could not analyze it.By a picture provided, the helix drill snapped in half.Pms data: according to our pms data, 16 complaints for a total of 18 breakages were reported on the v.00 helix drills with product codes 9084.20.081 and 9084.20.086 on a total of 1200 v.00 helix drill manufactured with the product codes involved.Helix drills involved in these complaints were manufactured according to specifications.Breakage of drill bits is a common and expected occurrence in orthopaedic surgery since twisting of the bit and torque accidentally applied by the surgeon during drilling can lead to breakage of the drill.Capas: in may 2016, after receiving similar complaints, lima corporate decided to modify the technical drawings of the helix drills with product codes 9084.20.081 - 9084.20.086, by increasing the core diameter of the instruments (v.01 helix drills).This product enhancement was introduced in order to increase the helix drills mechanical strength and reduce the risk of occurrence of intra-op breakage.Lima corporate will keep monitoring the market to verify the effectiveness of the above corrective action.

Event Description

Intra-operative breakage of helix drill (product code 9084.20.081, lot #1413691).Surgeon was drilling the glenoid bone with the helix drill and drill guide when the helix drill broke into two pieces.Surgery completed using the long drill bit.No consequences for the patient.Event occurred in (b)(6).

• Brand Name: HELIX DRILL D. 3.5MM
• Type of Device: HELIX DRILL D. 3.5MM
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, italy (udine) 33038 ; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 6092751
• MDR Text Key: 60086693
• Report Number: 3008021110-2016-00037
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Model Number: 9084.20.081
• Device Lot Number: 201413691
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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