MAUDE Adverse Event Report: AESCULAP AG & CO KG TAPER BURR D1.2MM UL4.0MM 2.35X51MM; BONE CUTTER

Model Number GD950R

Device Problem Break (1069)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).After an oral surgery, it was confirmed that the tip of this product was broken and it was possible that the fragment remained in the patient's jaw.X ray confirmed the piece was not retained in the patient.

Manufacturer Narrative

Us reporting agent notified on: (b)(4) 2014.Visual inspection showed that the working end was missing on the received tool.The sample received is approx.46.8mm; the length in total should be approx 50.98 mm (+/- 0.254mm).Received product is approx.4mm shorter than specification.The missing 4mm part is the working end of the tool.According to the received info, the broken off piece was confirmed not to be in the patient (x-ray).In addition, the broken off piece was not forwarded for investigation.A microscopic inspection of the breakage surface was performed and it showed a slight black discoloration.In addition, the breakage surface showed a small platform (about one third of the surface).The entire surface shows a clear breakage without corrosion or other abnormalities.The breakage characteristics follow a pattern of an overload situation.The black discoloration on the breaking surface is an indicator that the tool also experienced an excessive warming.The breakage structure does not indicate a material or manufacturing deficiency.

• Brand Name: TAPER BURR D1.2MM UL4.0MM 2.35X51MM
• Type of Device: BONE CUTTER
• Manufacturer (Section D): AESCULAP AG & CO KG; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): AESCULAP AG&CO KG; po box 40; tuttlingen 7850 1; GM 78501
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4289150
• MDR Text Key: 21878096
• Report Number: 2916714-2014-00829
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GD950R
• Device Catalogue Number: GD950R
• Date Manufacturer Received: 07/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other