MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 12 HOLES/313MM; PLATE, FIXATION, BONE

Model Number	242.125
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2019, the patient underwent a removal surgery due to a broken locking compression plate (lcp) proximal femoral hook plate.Originally, the patient was treated with open reduction internal fixation (orif) with plates and screws on (b)(6) 2019.The broken lcp proximal femoral hook plate was removed and an eight (8) hole hook plate was applied and secured in place with multiple cables.The procedure was done without complications.The patient progressed well with physical therapy.Concomitant device reported: cannulated locking screw (part # 02.205.025, 02.207.035, lot # unknown, quantity # 2); locking screw (part # 212.214, lot # unknown, quantity # 3); cerclage positioning pins (part # 298.803s, lot # h326726, h808924, quantity # 2), cerclage cable with crimp (part # 298.801.01s, 298.800.01s, lot # p330808, p291870, p237260, quantity # 5).This complaint involves one (1) device.This report is for one (1) 4.5 mm lcp® proximal femur hook plate 12 holes / 313 mm.This is report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM LCP® PROXIMAL FEMUR HOOK PLATE 12 HOLES/313MM
• 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: 9174930
• Report Number: 2939274-2019-61383
• Device Sequence Number: 2811911
• Product Code: HRS
• UDI-Device Identifier: 10886982168160
• UDI-Public: (01)10886982168160
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K032032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2019

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: 242.125
• Device Catalogue Number: 242.125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 113