MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM LCP® PROXIMAL FEMUR PLATE 8 HOLES/247MM-LEFT; PLATE, FIXATION, BONE

Model Number	242.108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Date of event is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device lot number 5480313.Manufacturing location: (b)(4).Date of manufacture: 20 apr 2007.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device history record shows this lot of 4.5mm lcp proximal femur plates was processed through the normal manufacturing and inspection operations with no non-conformance noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.The review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that 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.
Event or Problem Description
It was reported that a patient underwent hardware removal and revision of the left proximal femur on (b)(6) 2017 due to infection.The original procedure was performed on an unknown date in 2012.Approximately (1-2) one to two months prior to the revision date, the patient was referred to the surgeon for treatment of an abscess of the left proximal femur.No information was provided on whether the patient had symptoms related to this event.It is unknown how the diagnosis of infection was detected.Removed hardware included: one plate and screws, all intact.Antibiotic cement was placed in the incision operative site, and a new provisional plate and screws was placed.Nothing untoward occurred during the procedure.The procedure was completed successfully with the patient in stable condition.No surgical delay reported.The patient will be scheduled for additional future staged procedures.This is report 1 of 12 for com-(b)(6).

• Brand Name: 4.5MM LCP® PROXIMAL FEMUR PLATE 8 HOLES/247MM-LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6725693
• Report Number: 3003506883-2017-10136
• Device Sequence Number: 16336418
• Product Code: HRS
• UDI-Device Identifier: 10886982167965
• UDI-Public: (01)10886982167965(01)5480313
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K030858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 242.108
• Device Catalogue Number: 242.108
• Device Lot Number: 5480313
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 68