MAUDE Adverse Event Report: UMKIRCH DOUBLE AIR HOSE SYNTHES STEM 3 METERS; INSTR, SURGICAL, ORTHO, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number 519.510

Device Problem Break (1069)

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

Event Date 04/22/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the device was connected to a compact air drive suddenly broke with an explosion sound during use.There were no adverse consequences to the patient or the surgeon.There was a ten minute delay in the procedure.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing evaluation was completed: the device was received used and decontaminated by the user facility.The investigation has shown, that a green hose was correct assembled but is damaged due to the wrong usage and aging and that the air hose fits smoothly with the function gages; both couplings runs with smooth motions.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history records was requested: no documents are available in (b)(4).It is possible that the serial number (b)(4) was shipped as a spare part to a repair service.Part 519.510 serial number (b)(4) was booked in (b)(4) on oct 06, 2010.Serial number (b)(4) was never repaired in (b)(4).Since 2009, these hoses are no longer allowed to be repaired.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DOUBLE AIR HOSE SYNTHES STEM 3 METERS
• Type of Device: INSTR, SURGICAL, ORTHO, PNEUMATIC POWERED & 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: 3809638
• MDR Text Key: 4524783
• Report Number: 2520274-2014-11467
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2014

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: 519.510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 05/14/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2014; 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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