MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 20MM; SCREW,FIXATION,BONE

Model Number	204.820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: (b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).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 internal fixation (orif) of right proximal ulna on (b)(6) 2017.After that the patient complained of stiffness and so the surgeon had to do the revision surgery for removal of the plate and screws.The plate and the screws were intact and there was no malfunction with the device.The revision surgery was successfully completed without any surgical delay.The patient was stable after the surgery.This report is for one (1) 3.5mm cortex screw self-tapping 20mm.(b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 20MM
• 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: 7108507
• Report Number: 2939274-2017-50214
• Device Sequence Number: 13720319
• Product Code: HWC
• UDI-Device Identifier: 10886982146281
• UDI-Public: (01)10886982146281(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 11/13/2017

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: 204.820
• Device Catalogue Number: 204.820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/12/2017
• 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
• Patient Weight: 77