MAUDE Adverse Event Report: SYNTHES RARON 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/14H/237MM/RIGHT; PLATE,FIXATION,BONE

Catalog Number	02.127.260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional product code: hwc.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products: therapy dates: unknown.Medial proximal tibial plate (part # 239.958, lot # 6577675, qty.1); unknown 3.5 variable angle locking screws (part # 02.127.1xx, lot # unknown, qty.7); unknown 3.5 cortex screws (part # unknown, lot # unknown, qty.5); unknown 3.5 cortex screws (part # 204.8xx, lot # unknown, qty 2); unknown locking screws (part # 212.1xx, lot # unknown, qty 2); 2 unknown 3.5 cortex screws (part # 204.8xx, lot # unknown, qty.2), and washers (part # 219.98, lot # unknown, qty.2).This is a total of 21 concomitant parts.(b)(4).Device history records review was conducted.The report indicates that the: part # 02.127.260; lot # 9907498: manufacturing location: (b)(4), manufacturing date: 11.Apr.2016.No 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.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 was revised to a suprapatellar tibial nail on (b)(6) 2017 due to poor bone healing, nonunion, and a broken plate.The patient was originally implanted with a lateral proximal tibial plate, a medial proximal tibial plate and screws on (b)(6) 2017.The patient was walking postoperatively despite being instructed to be non-weight bearing.The patient subsequently had poor bone healing and nonunion.It was discovered on an unknown date that the lateral plate was broken.The lateral plate, seven 3.5 variable angle locking screws (02.127.1xx) and five 3.5 cortex screws were removed intact.The medial plate, four cortex screws (204.8xx), and two locking screws (212.1xx) were removed; two of the cortex screws were broken (all pieces were removed).Two 3.5 cortex screws (204.8xx) and two washers (219.98) from the initial surgery were left in the patient.A suprapatellar tibial nail (04.034.561s) and six 5.0 locking screws were implanted.The surgery was successfully completed with positive patient outcome.This complaint involves 3 devices.Reported concomitant devices; medial proximal tibial plate (part # 239.958, lot # 6577675, qty.1); unknown 3.5 variable angle locking screws (part # 02.127.1xx, lot # unknown, qty.7); unknown 3.5 cortex screws (part # unknown, lot # unknown, qty.5); unknown 3.5 cortex screws (part # 204.8xx, lot # unknown, qty 2); unknown locking screws (part # 212.1xx, lot # unknown, qty 2); 2 unknown 3.5 cortex screws (part # 204.8xx, lot # unknown, qty.2), and washers (part # 219.98, lot # unknown, qty.2).This is a total of 21 concomitant parts.This report is 1 of 2 for (b)(4).

• Brand Name: 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/14H/237MM/RIGHT
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6673470
• Report Number: 3006126083-2017-10027
• Device Sequence Number: 72112
• Product Code: HRS
• UDI-Device Identifier: 10886982043665
• UDI-Public: (01)10886982043665(10)9907498
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• 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): 05/31/2017

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 Catalogue Number: 02.127.260
• Device Lot Number: 9907498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 93