MAUDE Adverse Event Report: SYNTHES GRENCHEN DCP 4.5-BROAD 10HO L167 SST; PLATE, FIXATION, BONE

Catalog Number	226.100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Unknown if device was already broken.Device is not expected to be returned for manufacturer review/investigation.(b)(6).(b)(4).Device history records review was conducted.The report indicates that the: part#: 226.100 / lot #: 8773649.Manufacturing location: (b)(4).Manufacturing date: 8.Dec.2013.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.Review of the device history record(s) showed that there were no issues during the manufacture of this 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
Device report from synthes on an event in (b)(6) as follows: it was reported that the patient had an accident with an exposed femoral fracture on (b)(6) 2014.He underwent surgical procedure on (b)(6) 2014 and plate and screws were implanted for consolidation of the lesions.When the patient got up from the sofa on (b)(6) 2014 the dynamic compression plate (dcp) broke.A revision surgery was performed on (b)(6) 2014.Patient outcome is good and recuperating fine.This complaint involves 1 part.Concomitant reported parts: 2x cortex screw (part 214.038, lot 8821520 / 8821521).This report is 1 of 1 for com-(b)(4).
Additional Manufacturer Narrative
Device history record review: manufacturing date is 18-dec-2013.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
Patient was recuperating fine.Several months after the revision surgery patient noticed that the fracture was not healing and patient¿s left leg was crooked, could not support it on the ground, and needed to use crutches to move around.Patient revised again on (b)(6) 2015 as the plate implanted in the second surgery was not adequate for the size of his bone and had been set mistakenly.This issue has been addressed in the linked complaint (b)(4).
Additional Manufacturer Narrative
The given information on the device report has indicated that the dynamic compression plate (dcp) broke.Unfortunately the complained item was not returned for evaluation.Without having the material we cannot give a conclusive statement regarding the possible failure reason.No further information had been made available therefore an investigation could not be performed.This particular item was produced in december 2013 according to the specification.The review of the attached x-rays can be confirmed regarding the broken plate.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: DCP 4.5-BROAD 10HO L167 SST
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• MDR Report Key: 6352830
• Report Number: 3009450884-2017-10025
• Device Sequence Number: 933920
• Product Code: HRS
• UDI-Device Identifier: 10705034719115
• UDI-Public: (01)10705034719115(10)8224862
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2017

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: 226.100
• Device Lot Number: 8773649
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 03/29/2017; 04/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR