MAUDE Adverse Event Report: SYNTHES OBERDORF RADIOLUCENT-DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.300

Device Problem Poor Quality Image (1408)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported from (b)(6) that during the application of expert humeral nail (ehn) for a humeral diaphysis fracture surgery, it was observed that the image to see the holes to conduct the distal locking was hard to see on the radiolucent drive device.According to the reporter, the device was used to drill distal locking holes in intramedullary nailing procedure under image intensifier control.It was further reported that although the surgeon tried to adjust the contrast of the image, the attempts did not work well.As the image was not able to improve, the surgeon kept using the device to insert a screw into the hole and tightened it up under the bad image.It was reported that the surgeon used a three-fluted drill-bit device attached to a chuck device for another screw insertion and the tightening to complete the distal locking.The reporter indicated that, eventually, the distal locking was successfully completed.There was a fifteen minute delay to the surgical procedure.There was patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The reporter stated that there were no allegation of malfunction reported against the fluted drill bit device and the chuck device.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Additional narrative: correction: serial number: the device serial number provided by the reporter in the initial report was incorrect ((b)(4)).The serial number was identified as (b)(4).This information has been updated accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The device manufacture date was inadvertently missed on the previous report.The device manufacture date has been updated as oct 5, 2015.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the bush ((b)(4)) became loose and was partially unscrewed from the housing.It was further determined that the gear wheels were damaged and the coupling tool side was loose.Therefore, the reported condition was duplicated and confirmed.It was noted that it was probable the issue occurred due to improper handling.However, an assignable root cause could not be determined.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: RADIOLUCENT-DRIVE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5306064
• MDR Text Key: 34576013
• Report Number: 8030965-2015-12331
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK971544
• 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,Followup,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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