MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 48MM; SCREW,FIXATION,BONE

Model Number	204.848
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device procode: hrs, jds.Date of implant is an unknown date in (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 on an unknown date in (b)(6) 2016, patient underwent surgery to treat a left ankle fracture.Patient was implanted with one (1) 2.7mm/3.5mm lcp lateral distal plate and ten (10) screws.It was unknown to the surgeon if the patient was allergic to metal at the time of the initial surgery.Subsequently the patient felt some soft tissue irritation and this was discovered to be a reaction to metal allergy.The surgeon then decided to remove all implanted devices and the construct with all devices intact was removed on (b)(6) 2018.Intra-operative x-rays taken suggested that the fracture had completely healed.The removal of plate and screws construct was completed successfully and without any complications.No additional interventions were required and there was no surgical delay.The patient was reported to be in stable condition.This report is for one (1) 3.5mm cortex screw self-tapping 48mm this is report 7 of 11 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 48MM
• 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: 7242059
• Report Number: 2939274-2018-50508
• Device Sequence Number: 19079430
• Product Code: HWC
• UDI-Device Identifier: 10886982146434
• UDI-Public: (01)10886982146434(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2018

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: 204.848
• Device Catalogue Number: 204.848
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/05/2018
• 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 Weight: 82