MAUDE Adverse Event Report: SYNTHES GRENCHEN 135 DEG DHS® PLATE-STANDARD BARREL 6 HOLES/110MM; APPLIANCE,FIXATION,NAIL

Catalog Number	281.160
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 used for treatment, not diagnosis.Additional narrative: event date: unknown.Additional product code: hrs.The original surgery was performed in (b)(6) on an unknown date.Device is not expected to be returned for manufacturer review/investigation.The complaint indicated that the screws were explanted due to the possible infection.The complaint indicated that the plate broke post-op requiring additional surgical intervention.Device history records review was conducted.The report indicates that: dhr review for: part # 281.160, lot # 9347372; manufacturing location: (b)(4); manufacturing date: 06.Feb.2015.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 who was implanted approximately one year ago with a dynamic hip screw (dhs) plate, lag screw and screws experienced a post-operative break of the plate and screws and was revised on (b)(6) 2016 to a non-synthes total hip.The original surgery was performed in (b)(6) by an unknown surgeon.It was reported by the current surgeon that the devices, in his opinion, were not appropriate for the subtrochanteric fracture that the patient had originally sustained.The broken plate, intact lag screw and six screws were easily removed without any surgical delay, additional medical intervention of harm to the patient.Two of the six screws that were broken post-operatively were removed, without issue, using a screw removal set.The procedure was successfully completed and the patient status was reported as fine at the outcome of surgery.No additional information is available regarding the treatment outcome.This complaint involves three (3) devices.Concomitant devices reported: lag screw (part # 280.290, lot # 4811489, quantity 1), screws (part # 204.8xx, lot # unknown, quantity 4), screw removal set (part # unknown, lot # unknown, quantity 1).This report is 1 of 2 for (b)(4).

• Brand Name: 135 DEG DHS® PLATE-STANDARD BARREL 6 HOLES/110MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• MDR Report Key: 6226513
• Report Number: 3009450884-2017-10001
• Device Sequence Number: 43007
• Product Code: KTT
• UDI-Device Identifier: 10886982176721
• UDI-Public: (01)10886982176721(10)9347372
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2016

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: 281.160
• Device Lot Number: 9347372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2016
• Initial Report FDA Received Date: 01/05/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAG SCREW (PART # 280.290, LOT # 4811489, QTY. 1; SCREW REMOVAL SET (PART # , LOT # UNK, QTY UNK; SCREWS (PART # 204.8XX, LOT # UNKNOWN,QTY 4
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR