MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM LCP PROXIMAL TIBIA PLATE8 HOLES/154MM-LEFT; PLATE, FIXATION, BONE

Model Number	240.041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight not available for reporting.Device is not expected to be returned for manufacturer review/investigation.Device history records review was conducted.The report indicates that the: product manufacture date: 13-jan-2016.Product manufacture location: synthes(b)(4).A review of the device history record (dhr) revealed no complaint related anomalies.The (dhr) shows this lot of 4.5mm lcp proximal tibia plate 8 holes/154mm-left (part number 240.041, lot number 9978805) was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformances or rework noted.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 removal of a tibia plate, four cannulated locking screws, and three cortex screws due to infection, inflammation, and nonunion on (b)(6) 2017.The hardware was originally implanted on (b)(6) 2017 during an open reduction internal fixation (orif) proximal left tibial plateau fracture.The patient failed to follow postoperative directions which included removing bandage too early postoperatively and walking on leg before he was directed to.The surgeon stated that the infection was due to the patient's noncompliance.The surgery was successfully completed with no delay.The patient outcome was reported as okay.This complaint is (3) devices 1 plate, unk cortex screws, unk locking screws.This report is 1 of 3 for (b)(4).

• Brand Name: 4.5MM LCP PROXIMAL TIBIA PLATE8 HOLES/154MM-LEFT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6825934
• Report Number: 3003506883-2017-10187
• Device Sequence Number: 1324136
• Product Code: HRS
• UDI-Device Identifier: 10886982164537
• UDI-Public: (01)10886982164537(10)9978805
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052390
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: 240.041
• Device Catalogue Number: 240.041
• Device Lot Number: 9978805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 08/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR