MAUDE Adverse Event Report: SYNTHES GRENCHEN 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM; APPLIANCE, FIXATION, NAIL

Catalog Number	281.102
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional product code: jdo.Device malfunctioned intra-operatively and was not implanted / explanted.Concomitant medical products: therapy date: (b)(6) 2017: dhs reaming head- standard- unk part and lot numbers, qty.X 1; dhs triple reamer-complete- unk part and lot numbers, qty.X1; dhs/dcs wrench- part 338.06, unk lot number, qty.X 1; dhs/dcs centering sleeve-long -unk part and lot numbers, qty.X1; dhs/dcs coupling screw-short unk part and lot numbers, qty.X 1; dhs/dcs guide shaft - unk part and lot numbers, qty.X1; dhs centering sleeve long - part 338.19, unk lot number, qty.X 1; dhs coupling screw, long - part 338.22, unk lot number, qty.X 1.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part 281.102 /lot l195736; manufacturing location: (b)(4); manufacturing date: 02.Dec.2016.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 the patient under went a procedure on (b)(6) 2017.During the procedure the dynamic hip screw (dhs) 2-hole plate would not slide over the lag screw.The surgeon tried to use a dhs impactor to advance the lag screw but was not successful and pushed the lag screw into the patient's acetabulum.The surgeon then used a dhs coupling screw to engage the lag screw.The surgeon used pliers and a mallet to tap on the coulping screw and drag the lag screw halfway out of the bone.A dhs wrench was used to back turn and finally remove the lag screw.An additional x-ray was taken during the procedure for removal of the lag screw.These events did result in a 15 minute surgical delay.The procedure was resumed using an tfn-advanced proximal femoral nailing system (tfna).The procedure was successfully completed.The procedure was tolerated by the patient.This complaint involves 2 devices.Concomitant medical products dhs reaming head- standard- unknown part and lot numbers, quantity x 1; dhs triple reamer-complete- unknown part and lot numbers, quantity x1; dhs/dcs wrench- part 338.06, unknown lot number, quantity x 1; dhs/dcs centering sleeve-long -unknown part and lot numbers, quantity x1; dhs/dcs coupling screw-short unknown part and lot numbers, quantity x 1; dhs/dcs guide shaft - unknown part and lot numbers, quantity x1; dhs centering sleeve long - part 338.19, unknown lot number, quantity x 1; dhs coupling screw, long - part 338.22, unknown lot number, quantity x 1.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, device history record (dhr) review, functional test and drawing review were performed as part of this investigation.The complaint condition is unconfirmed as the implants were received intact and fully functional.When assembled properly with the flats aligned the plate smoothly slides over the lag screw.No resistance was encountered.Small dents were observed on the outer diameter of the proximal end of the lag screw and around the lag screw cannulation on the proximal end of the plate.The balance of each device is in good condition.Thus, as no functional issue was identified, the complaint condition for this device is unconfirmed and could not be replicated.The returned parts were determined to be suitable for their intended use when employed as recommended.The returned implants are part of the dhs/dcs dynamic hip and condylar screw system which is discussed in technique guide.During use the screw is inserted and then the plate is seated over the screw.No definitive root cause was able to be determined as the complaint condition is unconfirmed and could not be replicated with the returned parts.However, it is probable that the complaint condition was the result of not having the flats on the two implants aligned which then lead to the devices sticking together such that the lag screw was pushed medially.(b)(4).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: 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• MDR Report Key: 6386177
• Report Number: 3009450884-2017-10033
• Device Sequence Number: 10842210
• Product Code: KTT
• UDI-Device Identifier: 10886982176608
• UDI-Public: (01)10886982176608(10)L195736
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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: 281.102
• Device Lot Number: L195736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 04/07/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR