MAUDE Adverse Event Report: THE ANSPACH EFFORT, INC. XMAX; INSTRUMENT, SURGICAL, ORTHOPEDIC PNEUMATIC

Device Problems Air Leak (1008); Hole In Material (1293); Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

During a lumbar fusion case, the dr using the anspach drill cable had a hole blow out in it, approximately 4 inches long.This caused an extremely loud "pop" and a delay in the case as new equipment needed to be brought to the room.The hose used with the drill contains an inner nylon, braided cover that protects the inner lumen.There is also an outer rubber sheath that covers the braided cable hose.It is the outer rubber cover that ruptured.It is not clear if the rubber cover is there to indicate potential gas leaks while using the drill.There must have been some gas leakage from the inner tubing that built up pressure while using the drill causing pressure to exceed the rating of the rubber cover.Ultimately, leading to the rupture.
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manufacturer response for high speed pneumatic surgical drill, synthes anspach xmax pneumatic system (per site reporter).
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as of this report there has been no response from the manufacturer.

• Brand Name: XMAX
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC PNEUMATIC
• Manufacturer (Section D): THE ANSPACH EFFORT, INC.; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 4938416
• MDR Text Key: 22157853
• Report Number: 4938416
• Device Sequence Number: 1
• Product Code: HSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 100