MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM; PLATE, FIXATION, BONE

Model Number	226.622
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Date of birth not available for reporting it is unknown when plate broke.Original implant unknown date in (b)(6) 2017.Explant date unknown date in 2018.Device has not been returned for 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.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 the patient underwent revision surgery in (b)(6) 2017 due to loose wires and screws (unknown manufacturer).In (b)(6) 2018, it was determined the patient's synthes plate snapped in half and she had to have additional surgery for all new hardware to be implanted.She was using a walker and only partial weight bearing on that leg.The patient originally fractured left femur in (b)(6) 2017.The devices were originally implanted during an open reduction internal fixation (orif) of her left femur in (b)(6) 2017.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CURVED BROAD LCP® PLATE 12 HOLES/229MM
• 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: 7403645
• Report Number: 2939274-2018-51521
• Device Sequence Number: 18849774
• Product Code: HRS
• UDI-Device Identifier: 10886982159168
• UDI-Public: (01)10886982159168(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 226.622
• Device Catalogue Number: 226.622
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/06/2018
• 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: 74 YR
• Patient Weight: 70