MAUDE Adverse Event Report: SYNTHES OBERDORF 2.7MM THREE-FLUTED RADIOLUCENTDRILL BIT/BRAD POINT/150MM; BIT, DRILL

Catalog Number 511.413

Device Problem Device Inoperable (1663)

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

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

The product code was unknown; therefore, the brand name, catalog number, and 510(k) were unknown.The manufacturing location was unknown.The lot/serial number was unknown; therefore, the device manufacturer date was unknown.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 report 3 of 3 for the same event.It was reported from (b)(6) that during a surgical procedure for a tibial diaphysis fracture, it was observed that the drill bit device stopped moving during the insertion of distal side locking using a radiolucent drive device and a battery handpiece device.It was reported that when the devices were checked on the instrument table, it was observed that the radiolucent drive device was spinning around.As a result, the side stopping was inserted manually.It was reported that there was a 20 minute delay in the procedure due to the event.It was not reported if spare devices were available for use.There was patient involvement reported.There were no patient or user injuries reported.It was reported there was no medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

It was documented in the initial medwatch report that there were three devices involved in the same event.During subsequent follow-up with the reporter, additional information was obtained.The reporter stated that there was an adapter device and five additional drill bit devices (a total of six additional devices) involved in the same event.Therefore this device represents 3 of 9 devices involved in the same event.Udi - (b)(4).The manufacturer location was documented as unknown in the initial report.The location has been updated to (b)(4).Contact office name/address has been updated accordingly to reflect the corrected manufacturing facility.The lot/serial number was documented as unknown in the initial medwatch report.The lot number has been received (u211542) and has been entered.Please note that the brand name, common device name, device product code and 510k number were documented as unknown in the initial medwatch report.Upon product receipt, all device information have been updated accordingly.The previous report stated the date of manufacture (dom) was unknown.The dom (dec 18, 2014) has been updated to reflect the date the device was manufactured.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Manufacturer Narrative

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device passed all operational specifications and no failure was identified.Therefore, the reported condition was not confirmed and an assignable root cause was not determined.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 2.7MM THREE-FLUTED RADIOLUCENTDRILL BIT/BRAD POINT/150MM
• Type of Device: BIT, DRILL
• 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: 6813463
• MDR Text Key: 83518821
• Report Number: 8030965-2017-14525
• Device Sequence Number: 1
• Product Code: HTW
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.413
• Device Lot Number: U211542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1