MAUDE Adverse Event Report: AAP IMPLANTATE AG SCREWDRIVER DUO, SW 3.5 QUICK COUPLING

Model Number IU 7835-65

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

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

Event Date 04/30/2014

Event Type  malfunction  

Event Description

Drill bit broke off during surgery.

Manufacturer Narrative

The sixhead of the screwdriver broke of during insertion of the plate.The part which broke off has been not returned to the mfr.The screwdriver is about two years old.Depending on the quantity of usages and the forces that apply a wear out could occur and a breakage is the result.The screwdriver showed no further damages.

• Brand Name: SCREWDRIVER DUO, SW 3.5 QUICK COUPLING
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): AAP IMPLANTATE AG; lorenzweg 5; berlin 1209 9; GM 12099
• Manufacturer Contact: marc seegers ; lorenzweg 5; berlin 12099 ; GM 12099 ; 9307501919
• MDR Report Key: 3905788
• MDR Text Key: 22263649
• Report Number: 8043862-2014-00006
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IU 7835-65
• Device Lot Number: I004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other