MAUDE Adverse Event Report: LIMACORPORATE S.P.A. LONG HELIX DRILL D.36MM

Model Number 908420086

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Dhr: the check of the dhr of the lot number involved (201411377) did not show any pre-existing anomaly on the 50 helix drill manufactured with this lot number.

Event Description

Intra-operative breakage of helix drill (product code 9084.20.086, lot #201411377).Surgeon was drilling the glenoid bone when the helix drill broke in half.Surgery completed with no consequences for the patient.Event occurred in us.

Manufacturer Narrative

Dhr: the check of the dhr of the lot # involved (201411377) did not show any pre-existing anomaly on the 50 helix drill manufactured with this lot #.Pms data: according to our pms data, (b)(4) complaints for a total of (b)(4) breakages were reported on the v.00 helix drills with product codes 9084.20.081 and 9084.20.086 on a total of (b)(4) 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, limacorporate 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.Limacorporate will keep monitoring the market to verify the effectiveness of the above corrective action.

Event Description

Intra-operative breakage of helix drill (product code 9084.20.086, lot #201411377).Surgeon was drilling the glenoid bone when the helix drill broke in half.Surgery completed with no consequences for the patient.Event occurred in us.

• Brand Name: LONG HELIX DRILL D.36MM
• Type of Device: LONG HELIX DRILL D.36MM
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale,52; villanova di san daniele, udine 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: 6116077
• MDR Text Key: 79927091
• Report Number: 3008021110-2016-00062
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,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: 908420086
• Device Lot Number: 1411377
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2016
• Date Device Manufactured: 09/25/2014
• 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