MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 1.5MM TI EXTENDED H-PLATE/ RIGHT; PLATE,FIXATION,BONE

Model Number	446.482
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is unknown.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).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 a patient the patient was initially implanted with the plate and eight (8) cortex screws on an unknown date to treat a fracture on one unknown finger on the right hand.Subsequently, during a karate practice, patient punched someone and fractured the same bone at the base of the implant.The surgeon decided to revise the patient to another plate.Patient underwent revision surgery on (b)(6) 2018.During the revision, surgeon removed one (1) 1.5 mm ti extended h-plate/ right and eight (8) 1.5 mm cortex screws.Patient was revised to an unknown construct including one (1) 1.5 mm ti extended h-plate/ right.The revision surgery was completed successfully without any untoward incidents.The patient was reported to be stable.This report is for one (1) 1.5 mm ti extended h-plate/right.This is report 1 of 2 for (b)(4).

• Brand Name: 1.5MM TI EXTENDED H-PLATE/ RIGHT
• 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: 7260551
• Report Number: 2939274-2018-50578
• Device Sequence Number: 13758764
• Product Code: HRS
• UDI-Device Identifier: 10886982223685
• UDI-Public: (01)10886982223685(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 01/19/2018

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: 446.482
• Device Catalogue Number: 446.482
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: 43 YR
• Patient Weight: 84