MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.730

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

Reporter's complete address and phone number were not provided.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device failed pretest for general condition, marking and labeling and check canulation.The some parts of the inside of the drill chuck were jammed.It was not possible to open the drill chuck without excessive force, the clamping of the chuck could not be performed properly.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

This is report 1 of 2 of the same event.It was reported from (b)(6) that during a femoral trochanteric fracture (left) surgical procedure, it was observed that while attaching the cutter device to the chuck device it was hard to tighten the chuck using the spare key device.There was a five minute delay to the surgical procedure while changing out the cutter device.The surgery was completed successfully.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The date returned to manufacturer was documented as feb 14, 2018 on the initial report.It has been updated as feb 13, 2018.Device evaluation: it was reported in the initial report that the device failed pretest for general condition, marking & labeling and check canulation.Upon complaint review, it was determined that the device failed the following pretests instead: check drill chuck, check clamping range of drill chuck, check handpiece coupling and function test.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7317685
• MDR Text Key: 101720172
• Report Number: 8030965-2018-51754
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 7611819036420
• UDI-Public: (01)7611819036420(11)111222(10)7683838
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.730
• Device Lot Number: 7683838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1