MAUDE Adverse Event Report: LIMACORPORATE S.P.A. LONG HELIX DRILL DIA 3.5MMX79MM; HTW

Model Number 9084.20.086

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

During a surgery, the breakage of the drill bit occurred, probably when drilling the glenoid bone.Because of the breakage, a small piece of drill bit remained wedged inside patient glenoid.We received the following additional info on the event: "patient result was not compromised in any way.Just unsightly to have a piece of drill bit behind the glenoid component.We would have caused more harm in trying to remove the item vs.Leaving it." the event occurred in the us.

Manufacturer Narrative

The check of the manufacturing charts of the lot # involved (201411377) did not show any pre-existing anomaly on the 50 pieces released on the market with this lot #.We received no other complaints on this lot #.We received no additional info (e.G.Return of the "free" piece of drill bit for analysis, post-op x-ray) on this event, therefore we cannot perform a deeper investigation.It's possible that an improper action by the surgeon caused unexpected stresses on the drill bit and consequently its intra-op breakage when drilling the bone.This is the 1st complaint reported on a drill bit belonging to this family (model # 9084.20.08x).According to our pms data, the breakage rate of these devices is 0.24%.No corrective actions have been planned for this case.Limacorporate will keep monitored the market to promptly detect a possible recurrence of such issue.Device not returned.

• Brand Name: LONG HELIX DRILL DIA 3.5MMX79MM
• Type of Device: HTW
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A.; via nazionale 52; san daniele del friuli, udine 3303 8; IT 33038
• Manufacturer Contact: giulio puppa ; via nazionale 52; san daniele del friuli, udine 33038 ; IT 33038
• MDR Report Key: 4548324
• MDR Text Key: 17936221
• Report Number: 3008021110-2015-00004
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2015

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: 9084.20.086
• Device Lot Number: 201411377
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2014
• 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): Hospitalization
• Patient Age: 72 YR