MAUDE Adverse Event Report: SYNTHES OBERDORF COMPACT AIR DRIVE II (CAD II); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.701

Device Problems Incorrect Or Inadequate Test Results (2456); Physical Resistance (2578); Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Reporter¿s phone number: (b)(6).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to premature wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was discovered that the motor power was too low on the compact air drive device.It was further determined that the soft mode switch resistance was too low.It was further determined during the pre-repair diagnostics assessment that the device failed for checks during check function of soft mode switch (safety system) and for check the power with test bench.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: COMPACT AIR DRIVE II (CAD II)
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer (Section G): SYNTHES OBERDORF; eimattstrasse 3; oberdorf CH443 6; SZ CH4436
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6112790
• MDR Text Key: 60801707
• Report Number: 8030965-2016-15627
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.701
• Device Lot Number: N/I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1