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

Catalog Number 519.510

Device Problems Air Leak (1008); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported from (b)(6) that during a femoral diaphyseal spiral fracture surgical procedure, during drilling the hole for bone fenestration before inserting the blade, it was observed that the hose burst on the compact air drive device.According to the report, there was a ¿huge explosion sound¿ and air was leaking.There was a one minute delay to the surgical procedure as a result of the event.It was reported that a spare device was available for use to complete the procedure safely.The reporter stated that the device was checked postoperatively, and it was observed that the pressure of nitrogen for equipment in the operating room was set to 140 pounds per square inch(psi), when the recommended operation pressure was supposed to be 87 psi.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All the available information has been disclosed.If any additional information should become available, this record will be updated accordingly.

Manufacturer Narrative

Udi: (b)(4).Mfr site: the manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).Device manufacture date: the device manufacture date was documented as unknown in the initial report.The device manufacture date has been updated as aug 11, 2004.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the hose was in a bad torn condition, had tears visible in the outer tube, inner hose was tight, markings were worn but still visible, couplings worked according to the specification and that the hose could not be used with this defect.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.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-792 24; GM D-79224
• Manufacturer (Section G): UMKIRCH; im kirchenhurstle 4; ni; umkirch b. freiburg D-792 24; GM D-79224
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6743418
• MDR Text Key: 81008350
• Report Number: 8030965-2017-13858
• Device Sequence Number: 1
• Product Code: HSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2004
• 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