MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 36MM; PLATE,FIXATION,BONE

Model Number	204.836
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Additional classification code: hwc, jds.Explant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 report that the patient had original surgery on (b)(6) 2017 for treatment of a distal tibial fracture.Patient was implanted with one (1) 3.5 mm- 8 hole anterior lateral distal tibial plate, one (1) 3.5 mm cortex self-tapping 36 mm screw, four (4) 2.7 mm cortex screws and one (1) unknown type screw that was implanted in the plate shaft.During the procedure, and after the surgeon had implanted all of the screws onto the plate for bone compression, he attempted to remove the previously implant 3.5 mm cortex self-tapping 36 mm screw.This screw position was implanted at the middle screw hole on the plate.While using a 2.5 mm drill bit to remove this screw and due to patient bone density the screw head broke off.The distal portion of the previously implanted screw remained in the patient¿s bone.Hospital has retained the broken screw head portion.Surgery was completed successfully with no time delay.Patient is reported in stable condition.Sales consultant has no more information to report on this event.Concomitant devices: unknown drill bit; (item number unknown, lot number unknown), quantity 1 each.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 36MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7075785
• Report Number: 1719045-2017-50010
• Device Sequence Number: 927628
• Product Code: HRS
• UDI-Device Identifier: 10886982146366
• UDI-Public: (01)10886982146366(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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: Health Professional
• Device Model Number: 204.836
• Device Catalogue Number: 204.836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1