MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG OBWEGESER RAMUS SPLITT OSTEOTOME, 12MM, 21.5CM; INSTRUMENT

Catalog Number 01-17871

Device Problem Break (1069)

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

Event Date 07/08/2014

Event Type  malfunction  

Event Description

It was reported during initial use of the device in a mandible surgery, the end of the blade was damaged.A back up device was used to complete the surgery.

Manufacturer Narrative

The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.

Manufacturer Narrative

The reported event could be confirmed, because fragments are broken off the cutting edge.The investigation result shows that the deformation and the broken off fragments of the osteotome were caused by high bending loads during surgery.Considering the technical investigation results there are no indications for any systematic design, material or manufacturing related issue.Indications for material or manufacturing related problems were not found in this investigation.

Event Description

It was reported during initial use of the device in a mandible surgery, the end of the blade was damaged.A back up device was used to complete the surgery.

• Brand Name: OBWEGESER RAMUS SPLITT OSTEOTOME, 12MM, 21.5CM
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: julie schoell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 4081188
• MDR Text Key: 4893509
• Report Number: 0008010177-2014-00253
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2014

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 Catalogue Number: 01-17871
• Device Lot Number: 1000135255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/19/2014
• Initial Date FDA Received: 09/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1