MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 50MM; SCREW, FIXATION, BONE

Model Number	204.850
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for a cortex screw/unknown lot.Lot number is unknown.Additional procode jds.Explanted date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 reported that a patient had an open reduction and internal fixation (orif) of ankle and calcaneus done on (b)(6) 2017.After some time the talus fell into a tilt because of an over-reduction of syndesmosis.So a revision surgery was performed and two 3.5mm cortex screws and two 4.0mm cannulated screws were removed.The fibula was re-reduced and two 3.5mm cortical syndesmosis screws were placed in the last two holes.An acumed medial hook plate was placed on the medial malleolus.The surgery was successfully completed with stable patient outcome and no surgical delay.This complaint involves three (3) devices.This report is for a cortex screw.This report is 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Date reported incorrectly on initial mw.It should have been (b)(6) 2017.Without a lot number the device history records review could not be completed.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.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7158607
• Report Number: 2939274-2018-50021
• Device Sequence Number: 111096
• Product Code: HWC
• UDI-Device Identifier: 10886982146441
• UDI-Public: (01)10886982146441(10)UNKNOWNLOTNUMBER
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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,Followup
• Report Date (Section B): 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 204.850
• Device Catalogue Number: 204.850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/02/2018
• Supplement Report FDA Received Date: 01/31/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 75