MAUDE Adverse Event Report: UMKIRCH DOUBLEAIRHOSE L3M F/SYST-SYNTHES; INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT

Catalog Number 519.510

Device Problem Air Leak (1008)

Patient Problem No Code Available (3191)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

This is report 3 of 3 for the same event.It was reported from (b)(6) that during an osteoarthritis surgery with ¿tomofix¿, it was discovered that the compact air drive device did not work when used together with the oscillating saw attachment device and a hose device.According to the reporter, the device leaked air from the hose connector and did not work.The reporter further indicated that the device worked when the device was used with the quick coupling or jacobs chuck devices.There was a fifteen delay to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

There was no contact phone number or complete address provided.Common device name and device product code was unknown.The catalog number and lot number were unknown.Pma/510(k) number was unknown the manufacturing location was unknown.The lot number was unknown; therefore, the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The product information was not provided by the reporter in the initial report.Therefore, all of the product information was documented as unknown.Upon receipt of the product, the device information was updated accordingly.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and no failures were identified.Therefore, the reported condition was not confirmed.The assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DOUBLEAIRHOSE L3M F/SYST-SYNTHES
• Type of Device: INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-79 224; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-79 224; GM D-79224
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4766709
• MDR Text Key: 5947241
• Report Number: 2520274-2015-13610
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

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 Catalogue Number: 519.510
• Device Lot Number: 41508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OSCILLATING SAW ATTACHMENT DEVICE; COMPACT AIR DRIVE DEVICE; QUICK COUPLING DEVICE; JACOBS CHUCK DEVICE