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

Catalog Number 511.300

Device Problem Vibration (1674)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reporter number was not provided.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

This is event 3 of 4 of the same event.It was reported from (b)(6) that during a diaphyseal spiral surgical procedure for a humeral diaphysis fracture, it was observed that while using the radiolucent drive device the drill bit devices started to wobble.According to the reporter, the drill bit devices then stopped moving while in use with the device.The reporter stated that the surgeon attempted to drill while holding the base tight as the surgeon believed there was a connection issue with the handpiece device.However, the surgeon noted that the junction of the drill bit device and quick coupling device did not work properly.The reporter stated that the surgeon then attempted to fix the drive tip with tape so that the drill bit device would not fall without success.The reporter stated that eventually the drill but device tip was hit with a hammer.Therefore, the surgeon opened the other side with his hand and inserted screw devices to continue the surgical procedure.The reporter further indicated that a compact air drive device was in use during the procedure.According to the reporter, the cutter device did not break during the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.There was a thirty minute delay to the surgical procedure which caused the patient to lose blood.The amount of blood loss was not available from the reporter.The reporter was not able to specify if/what medical intervention was performed or if there was prolonged hospitalization as a result of the event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

(b)(4).During subsequent follow-up with the customer, it was reported that there was an additional cutter device involved in this event.Therefore, this is report 3 of 5 of the same event.(b)(4).(b)(6).The date of manufacture was documented as unknown in the initial report and has been updated as oct 26, 2000.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

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.

Manufacturer Narrative

The date returned to manufacturer was documented as jan 27, 2017 on the initial report.It has been updated as feb 1, 2017.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all operational specifications.There was no failure identified.Therefore, the reported condition was not confirmed.An assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6221345
• MDR Text Key: 63824430
• Report Number: 8030965-2017-10023
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971544
• 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: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• 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: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2000
• 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
• Treatment: COMPACT AIR DRIVE; CUTTER DEVICE; QUICK COUPLING DEVICE
• Patient Outcome(s): Required Intervention