MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.5MM CURVED BROAD LCP® PLATE 15 HOLES/282MM; PLATE, FIXATION, BONE

Model Number	226.652
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history review part no.: 226.652.Lot no.: 9243436 manufacturing location: (b)(4).Release to warehouse date: november 10, 2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation was performed for the subject device (lcp plate, part number 226.652, lot number 9243436).The subject device was returned with the complaint condition stating the device was found to be broken at the eighth hole; significant deformation and cracking is apparent at the same hole.The complaint was confirmed.The complaint condition was unable to be replicated due to post-manufacturing damage.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.The root cause of the event is unknown a device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.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 due to a broken 4.5mm curved broad lcp plate on (b)(6) 2017.The plate, seven (7) locking screws, two (2) 1.7mm cables and three (3) 4.5mm threaded positioning pins, were originally implanted on (b)(6) 2017 during a periprosthetic midshaft femur fracture procedure with knee stem.During the revision the broken plate, and intact screws, cables and pins were all removed successfully and the patient was revised to a new set of implants.No surgical delay was reported and patient was listed as stable after the surgery.Concomitant devices reported: part # 212.202, lot # unknown, quantity # 1, part # 212.212, lot # unknown, quantity # 1 , part # 212.213, lot # unknown, quantity # 1 , part # 212.214, lot # unknown, quantity # 3 , part # 212.218, lot # unknown , quantity # 1 , part # 298.801.01s, lot # p269025, quantity # 1 , part # 298.801.01s, lot # p276185, quantity# 1 , part # unk - pins/wires, lot # unknown, qty # 3.This report is 1 of 1 for (b)(4).

• Brand Name: 4.5MM CURVED BROAD LCP® PLATE 15 HOLES/282MM
• 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: 7206827
• Report Number: 2939274-2018-50323
• Device Sequence Number: 917883
• Product Code: HRS
• UDI-Device Identifier: 10886982159243
• UDI-Public: (01)10886982159243(10)9243436
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2017

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: 226.652
• Device Catalogue Number: 226.652
• Device Lot Number: 9243436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 12/30/2017
• Initial Report FDA Received Date: 01/19/2018
• 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: 76 YR
• Patient Weight: 24