MAUDE Adverse Event Report: SYNTHES MONUMENT 3.5MM DCP® PLATE 7 HOLES/85MM; PLATE,FIXATION,BONE

Catalog Number	248.07
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
(b)(6).Patient weight is not available for reporting.Date of initial implant procedure is unknown.Approximately ten years prior to the awareness date of (b)(6) 2017.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 248.07, lot# 25639.Manufacturing location: (b)(4), release to warehouse date: apr 29, 1991.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 patient had original surgery for a right humerus fracture approximately ten years ago.During that initial surgery, a small piece of a 2.5 mm synthes drill bit broke and was left implanted inside the bone.Post operatively the implants were bothering the patient.Hardware removal was performed on (b)(6) 2017 and a plate and 5 screws were removed, all were intact and removed without any issue.There were no issues or delay during the revision surgery and the patient was reported as stable.The patient was not implanted with new hardware.(b)(4) captures the event (broken drill bit) occurred during initial implant procedure.This report is for one (1) 3.5 mm dcp plate.This is report 1 of 6 for (b)(4).

• Brand Name: 3.5MM DCP® PLATE 7 HOLES/85MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6339769
• Report Number: 1719045-2017-10118
• Device Sequence Number: 1611038
• Product Code: HRS
• UDI-Device Identifier: 10886982171085
• UDI-Public: (01)10886982171085(10)25639
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 01/24/2017

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: 248.07
• Device Lot Number: 25639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention