MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; PLATE, FIXATION, BONE

Model Number	02.124.413
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the tissue irritation began.Additional product codes: jdp, hwc.Implanted unknown date (b)(6) 2017.Complainant part is not expected to be returned for manufacturer review/investigation.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 one (1) broken distal femur plate, four (4) unknown cortex screws, and five (5) unknown va cannulated locking screws was performed on (b)(6) 2017.The original open reduction and internal fixation of distal femur was performed in the month of (b)(6) and the patient was subsequently discovered to a have a non-union due to a broken distal femur plate.The surgeon removed the broken plate, four cortex screws, and five va cannulated locking screws.All the screws were removed intact.The patient was revised to a new distal femur plate and screws.The revision surgery was performed uneventfully with no surgical delay.The patient outcome was as expected.Concomitant devices reported : unknown cortex screws (unknown part and lot number, quantity # 4), unknown va cannulated locking screws (unknown part and lot number, quantity # 5).This complaint involves one (1) device.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no.: 02.124.413, lot no.: l044095: manufacturing location: (b)(4), release to warehouse date: 06.Jul.2016: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Therapy date is (b)(6) 2017; exact date is unknown.Date of postoperative plate breakage is unknown.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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
• 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: 7126581
• Report Number: 2939274-2017-50351
• Device Sequence Number: 1259826
• Product Code: HRS
• UDI-Device Identifier: 10886982042873
• UDI-Public: (01)10886982042873(10)L044095
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• 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,Followup
• Report Date (Section B): 11/22/2017

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: 02.124.413
• Device Catalogue Number: 02.124.413
• Device Lot Number: L044095
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2017
• Supplement Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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