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

Model Number 204.836

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  malfunction  

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 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
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7075785
• MDR Text Key: 94639865
• Report Number: 1719045-2017-50010
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982146366
• UDI-Public: (01)10886982146366(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 204.836
• Device Catalogue Number: 204.836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2017
• Initial Date FDA Received: 12/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1