MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5 CURVED BROAD LCP PL 14 HOLES/265; PLATE,FIXATION,BONE

Model Number	226.642
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2021.Additional procode: hwc, ktt.Investigation summary: visual inspection: the 4.5mm curved broad lcp® plate 14 holes/265mm (p/n: 226.642, lot number: 39p5479) was received at us cq along with a photo attached in the complaint file.Visual inspection of the complaint device showed the plate had broken at the 7th hole.No material deficiencies were identified.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage and device geometry design.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the plate was broken at the 7th hole.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part: 226.642-us, lot: 39p5479, manufacturing site: (b)(4), release to warehouse date: jan 31, 2020.A manufacturing record evaluation was performed for the finished device 226.642-us lot: 39p5479 and no non-conformances were identified.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 (b)(6) 2021, the patient underwent revision due to curve broad locking compression plate breakage at the isthmus.Initially, patient had a zimmer total distal femoral replacement on (b)(6) 2021 and had a locking compression plate (lcp) curved croad plate placed to help support the junction between cut and proximal femur for additional support.The patient was converted to a full stem distal femoral prosthesis.The surgeon mentioned that the patient had great cortex at surgery and was supposed to be non-weight bearing for 6 weeks.Patient says he did not walk on it.Plate was removed safely and the patient was then converted to a full distal femoral replacement.It is unknown if there was surgical delay.Procedure outcome is unknown.No patient consequence.This report is for one (1) 4.5 curved broad lcp pl 14 holes/265.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5 CURVED BROAD LCP PL 14 HOLES/265
• 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: 11556155
• Report Number: 2939274-2021-01490
• Device Sequence Number: 4203869
• Product Code: HRS
• UDI-Device Identifier: 10886982159229
• UDI-Public: 10886982159229
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 226.642
• Device Catalogue Number: 226.642
• Device Lot Number: 39P5479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention