MAUDE Adverse Event Report: TRIMED, INC HEX DRIVER 2.0 70MM AO CANNULATED, SELF-DRILL CCSCREW LTHD 3.5, 30MM; HEX CANNULATED DRIVER, CANNULATED COMPRESSION SCREW

Model Number	DVHX-2.0-070C AO, L3528
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The initial complaint was received by (b)(4), trimed product manager on (b)(4) 2017.(b)(6), sales rep, explained via phone that she was just in a case with dr.(b)(6) where the dr.Was doing a proximal interphalangeal repair (pip).During insertion of the 3.5 screw, length 28mm (l3528), the 2.0 driver (dvhx-2.0/070c ao) got stuck in the screw head.When the surgeon tried to separate the driver from the screw head, she pulled on the finger and lost fixation.The screw would no longer pull the bones together and had to be removed.Eventually, the surgeon was able to remove the driver and the l3528 screw.The surgeon was then able to use a l3530 screw with the same driver to get bone purchase and completed the surgery successfully.

• Brand Name: HEX DRIVER 2.0 70MM AO CANNULATED, SELF-DRILL CCSCREW LTHD 3.5, 30MM
• Common Device Name: HEX CANNULATED DRIVER, CANNULATED COMPRESSION SCREW
• Manufacturer (Section D): TRIMED, INC; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 6825959
• Report Number: 2031009-2017-00024
• Device Sequence Number: 16541459
• Product Code: LXH
• UDI-Device Identifier: 00842188112713
• UDI-Public: 00842188112713
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/28/2017

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: No Information
• Device Model Number: DVHX-2.0-070C AO, L3528
• Device Catalogue Number: DVHX-2.0-070C AO, L3528
• Device Lot Number: 603314
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention