MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP 4.5/5 BROAD CURV 13HO L247 SST; PLATE,FIXATION,BONE

Model Number	226.632
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of event is unknown.Additional classification code: hwc, ktt.Implant date is unknown.Original implant was in (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.A device history record review was requested.(b)(4).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 hardware removal and revision of a 4.5 locking compression plate (lcp) curved broad femur plate and eleven unknown 5.0 locking screws and one unknown 1.7 mm cable was performed on (b)(6) 2018.All the hardware removed was intact except one plate and one screw backed out little bit from the plate.Revision surgery was completed successfully without any delay and patient is reported stable.Original surgery was performed on (b)(6) 2017 and post-operative x-rays confirmed plate breakage.The original event was orif (open reduction internal fixation) of femur for peri-prosthetic fracture.Patient was revised to the same procedure and a new depuy synthes hardware was implanted which included an unknown plate, unknown screws and 2 unknown cables.Concomitant devices reported: 5.0 locking screws (part # unknown, lot # unknown and qty - 10), cable (part # unknown, lot # unknown and qty 1).This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Device history records review was completed for part# 226.632, lot# 9331025.Manufacturing location: grenchen, release to warehouse date: jan 16, 2015.The device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and the used material was according to specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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.

• Brand Name: LCP 4.5/5 BROAD CURV 13HO L247 SST
• 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: 7498365
• Report Number: 2939274-2018-52104
• Device Sequence Number: 18868083
• Product Code: HRS
• UDI-Device Identifier: 10886982159182
• UDI-Public: (01)10886982159182
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• 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,Followup
• Report Date (Section B): 04/18/2018

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: 226.632
• Device Catalogue Number: 226.632
• Device Lot Number: 9331025
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 06/15/2018
• 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: 84 YR
• Patient Weight: 57