MAUDE Adverse Event Report: SYNTHES ELMIRA 3.5MM LCP PROXIMAL TIBIA PLATELOW BEND 16 HOLES/232MM/RIGHT -STER; PLATE,FIXATION,BONE

Model Number	02.124.224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient age and weight not provided for reporting.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was conducted.The report indicates that the: part number 02.124.224, lot number h109044, date of manufacture (release to warehouse date): 14 june 2016, place of manufacture: synthes usa- (b)(4), expiration date: 31 may 2025.Lot h109044, part number 02.124.224s, work order (b)(4).A review of the device history record (dhr) for lot h109044, part number 02.124.224s (description: 3.5 mm lcp proximal tibia plate low bend 16h/232 mm/right-sterile), work order 4475308 revealed zero manufacturing/complaint related anomalies.The documentation reviewed shows that lot h109044 was processed through normal manufacturing and inspection operations without any confirmed non-conformance's.The dhr evaluation confirms that the lot met all documentation, dimensional, and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Based on the information available, 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.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 on 09/15/2017 that on (b)(6) 2017, patient underwent hardware removal surgery due to nonunion.The initial surgery took place on (b)(6) 2016 for open reduction internal fixation (orif) for a proximal tibia fracture using depuy synthes devices.The nonunion caused the proximal tibia plate to break in half while the screws stayed intact.The revision procedure used the medical devices of smith and nephew (tibia plate and screws).There was no surgical delay, no fragments generated from broken device, no additional medical intervention or x-rays required.Surgery was completed successfully and patient outcome was stable.This complaint involves one part concomitant parts: screws(part number: 212.115, lot number unknown, quantity: 1), (part number: 212.129, lot number unknown, quantity: 1) (part number: 212.112, lot number unknown, quantity: 2), (part number: 212.239, lot number unknown, quantity: 2), (part number: 212.330, lot number unknown, quantity: 1), (part number: 02.200.030, lot number unknown, quantity:1) this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device 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.
Additional Manufacturer Narrative
Date of device breakage and non-union is not known.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: 3.5MM LCP PROXIMAL TIBIA PLATELOW BEND 16 HOLES/232MM/RIGHT -STER
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6911607
• Report Number: 3003506883-2017-10223
• Device Sequence Number: 18990852
• Product Code: HRS
• UDI-Device Identifier: 10886982042699
• UDI-Public: (01)10886982042699(10)H109044
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K011978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2017

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: 02.124.224
• Device Catalogue Number: 02.124.224
• Device Lot Number: H109044
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/03/2017; 10/25/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 10/03/2017; 10/25/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART NUMBER: 02.200.030, LOT NUMBER UNKNOWN, QTY 1; PART NUMBER: 212.129, LOT NUMBER UNKNOWN, QTY 2; PART NUMBER: 212.239, LOT NUMBER UNKNOWN, QTY 2; PART NUMBER: 212.330, LOT NUMBER UNKNOWN, QTY 1; SCREWS(PART NUMBER: 212.115, LOT NUMBER UNK, QTY 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR