MAUDE Adverse Event Report: SYNTHES MEZZOVICO 3.5MM LCP OLECRANON PLATE 2 HOLES/LEFT/86MM; APPLIANCE,FIXATION,NAIL

Catalog Number	236.503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient id used (b)(6).Date of event is unknown.Patient weight was not provided for reporting.Date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 236.503, lot# 9677846.Manufacturing location: (b)(4), manufacturing date: oct 14, 2015.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 the patient complained about implants were bothering patient.Hardware removal was performed on (b)(6) 2017 without any issues and all the seven (7) implants were explanted as intact.There was no surgical delay and procedure was completed successfully.Patient was reported as stable.Date of original implant is unknown.This report is for one (1) 3.5mm lcp olecranon plate.This is report 1 of 7 for (b)(4).

• Brand Name: 3.5MM LCP OLECRANON PLATE 2 HOLES/LEFT/86MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6456456
• Report Number: 1000562954-2017-10038
• Device Sequence Number: 16362524
• Product Code: KTT
• UDI-Device Identifier: 10886982160676
• UDI-Public: (01)10886982160676(10)9677846
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• 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): 03/14/2017

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?: No
• Operator of Device: Physician
• Device Catalogue Number: 236.503
• Device Lot Number: 9677846
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention