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

Model Number 9084.20.086

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the involved lot # (201212426) did not show any anomaly on the (b)(4) pieces manufactured with this lot #, thus indicating that the devices were released on the market in compliance with specifications.This is the first and only complaint received on this lot#.We will submit a final report once we conclude our investigation.

Event Description

On (b)(6) 2014 the patient underwent a shoulder revision surgery and the prosthesis implanted consisted of a l1 glenoid metal back with pe liner.No information received on the humeral components.In (b)(6) 2016 the patient started experiencing pain and according to the reported information, the surgeon believed that the liner was broken and that the head damaged the metal back glenoid.The revision surgery was not scheduled.Event occurred in (b)(6).

Manufacturer Narrative

Dhr: the check of the dhr of the lot # involved (201408146) did not show any pre-existing anomaly on the 51 helix drill manufactured with this lot #.Pms data: according to our pms data, (b)(4) complaints for a total of 19 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 #201408146).No many information available but even the helix drill broke in half, surgery was completed with no consequences for the patient.Event occurred in us.

• Brand Name: LONG HELIX DRILL D.3.5MM
• Type of Device: LONG HELIX DRILL D.3.5MM
• 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: 6127236
• MDR Text Key: 81253481
• Report Number: 3008021110-2016-00125
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 9084.20.086
• Device Lot Number: 1408146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2016
• Date Device Manufactured: 06/24/2014
• 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
• Patient Outcome(s): Required Intervention