MAUDE Adverse Event Report: SYNTHES ELMIRA 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT; PLATE, FIXATION, BONE

Model Number	222.658
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Additional device product codes: hty, jdw, hwc originally implanted in (b)(6) 2016.Complainant device is not expected to be returned for manufacturer review/investigation.Therapy date is (b)(6) 2016; exact date is unknown.A device history record (dhr) review was performed for part# 222.658 lot# h032887: product manufacture date: 22-feb-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 4.5 mm lcp condylar plate 8 holes/206 mm-right (part number 222.658, lot number h032887) 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a revision surgery on (b)(6) 2017 of a 4.5 mm locking compression plate (lcp) condylar plate and ten (10) screws of the distal femur.The patient was revised as the plate broke postoperatively due to nonunion.The plate and screws were originally implanted in (b)(6) 2016; and were replaced with a new plate and screws (unknown quantity) on (b)(6) 2017.The surgery was successfully completed with no delay and good patient outcome.Concomitant devices reported: screws (quantity 10).This report is for one (1) 4.5 mm lcp condylar plate.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6807911
• Report Number: 3003506883-2017-10176
• Device Sequence Number: 18865173
• Product Code: HRS
• UDI-Device Identifier: 10886982157324
• UDI-Public: (01)10886982157324(10)H032887
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K000066
• 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): 07/27/2017

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: 222.658
• Device Catalogue Number: 222.658
• Device Lot Number: H032887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/21/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 107