MAUDE Adverse Event Report: SYNTHES MONUMENT T20 HEXALOBE DRIVER-MALE; SCREWDRIVERS

Catalog Number	03.611.142
Medical Device Problem Codes	Bent (1059); Break (1069); Material Distortion (2977)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Device history records review was completed for part# 03.611.142, lot# 7247098.Supplier: (b)(4), release to warehouse date: apr 17, 2013.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported on (b)(6) 2016, that the t20 hexalobe driver-male screwdriver is twisted and deformed.There was no surgery or patient involvement.Upon receiving the device at manufacturer, it was noted that the drive tip was missing a segment (the distal-most 2.65mm of the tip).Additionally the tip was found to be twisted in a manner consistent with removal.This report is for one (1) t20 hexalobe driver-male.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product development investigation was performed for the hexalobe driver (part number 03.611.142, lot number 7247098).The subject device was returned with the complaint condition stating the returned driver was examined and the drive tip was found to be broken and missing a segment (the distal-most 2.65mm of the tip ¿ calipers).Additionally the tip was found to be twisted in a manner consistent with removal.The complaint condition was unable to be replicated due to post-manufacturing damage.The complaint was confirmed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.Relevant drawings for the returned device were reviewed the design, materials and finishing processes were found to be appropriate for the intended use of this device.A device history review was performed for the returned instrument¿s lot number and no non-conformance records or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.No definitive root cause was able to be determined as method of use at the time of failure is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: T20 HEXALOBE DRIVER-MALE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6176635
• Report Number: 1719045-2016-10916
• Device Sequence Number: 18935856
• Product Code: HXX
• UDI-Device Identifier: 10705034714424
• UDI-Public: (01)10705034714424(10)7247098
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.611.142
• Device Lot Number: 7247098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1