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 Air Leak (1008); Retraction Problem (1536); Calibration Problem (2890); Mechanical Jam (2983); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(4).(b)(6).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by (b)(6) that during service and evaluation, it was discovered that the motor seized, jammed and was moving heavy on the compact air drive device.It was further determined during the pre-repair diagnostics assessment that the device failed for check reverse locking mechanism, check triggers forward/reverse function, check for untrue running, check for excessive noise, check for air leak, check rotations per minute (rpms) with speedometer 850 rpm- max 1050 rpm and check the rpm with speedometer 110 w-max 150 w and for check starting behavior.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.

Manufacturer Narrative

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.It was further determined that the motor seized, jammed and was moving heavy.It was further determined that the device failed for check reverse locking mechanism, check triggers forward/reverse function, check for untrue running, check for excessive noise, check for air leak, check the rpm with speedometer 850 rpm-max 1050 rpm and check the rotations per minute (rpms) with speedometer 110 w-max 150 w and for check starting behavior.The assignable root cause was determined to be due to improper maintenance, which is user error, misuse, and / or abuse.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: 6082572
• MDR Text Key: 59556749
• Report Number: 8030965-2016-15488
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 04/17/2015

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: 511.701
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2015
• Initial Date FDA Received: 11/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2000
• 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