MAUDE Adverse Event Report: SYNTHES ELMIRA LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM; PLATE,FIXATION,BONE

Model Number	241.351
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.(b)(6).Device history records review was conducted.The report indicates that the: product manufactured in (b)(4).Product manufacture date: 06-may-2014.A review of the device history record (dhr) revealed no complaint related anomalies.The dhr shows this lot of lcp one-third tubular plate with collar 5 holes/57mm (part number 241.351, lot number 7675016) 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 1 nonconformance report (ncr) written against this lot of material.The ncr was written for two issues, the first an incorrect raw material certificate found at incoming inspection.As a result, a scar was issued to the supplier and the corrected certificate was returned by the supplier.The second issue was a cosmetic defect of a line along the length of some of the raw material.The raw material was deemed conforming, supported by two process tests.Due to the fact that this nonconformance would not affect the finished product, this ncr had no adverse effect on this complaint.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 on (b)(6) 2017 during a second revision surgery to treat bicondylar proximal tibia fracture of left leg, patient underwent hardware removal.The fracture did not heal as expected and the patient presented non-union.Due to this reason, this second revision surgery was performed.A total of three (3) plates and eighteen (18) screws were removed.One (1) plate was retained within the patient.All the implants were removed without any difficulty and were found be intact.There was no reported product problem.This 2nd revision surgery was completed successfully without any delay.The patient was implanted with a competitor¿s device (total knee, stryker) and is reported to be in stable condition.This complaint is for twenty one (22) devices.This report is 3 of 22 for (b)(4).
Additional Manufacturer Narrative
Patient height reported as (b)(6) centimeters additional patient identifier: (b)(6).Product was not returned and no lot number was provided.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.Upon review of the x-rays that were provided, an investigation cannot be performed as the complaint condition cannot be detected.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: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6947992
• Report Number: 3003506883-2017-10235
• Device Sequence Number: 10949010
• Product Code: HRS
• UDI-Device Identifier: 10886982166852
• UDI-Public: (01)10886982166852(10)7675016
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• 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): 09/26/2017

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: 241.351
• Device Catalogue Number: 241.351
• Device Lot Number: 7675016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/03/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 83