MAUDE Adverse Event Report: SYNTHES ELMIRA DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM; APPLIANCE, FIXATION, NAIL

Catalog Number 280.850

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight not provided for reporting.Date returned to manufacturer.Device malfunctioned intra-operatively and was not implanted / explanted concomitant devices reported: 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: dhr review for part # 280.850 lot # h167765; release to warehouse date: 18 august 2016; manufacturing site: (b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of dhs/dcs lag screw 12.7mm thread/85mm product was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications and the finished lag screw cannulation internal diameter feature does not contact the mating dhs plate sliding surface.The remaining 2130 ft of this raw material lot conformed and was accepted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture 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 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 coupling 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 devices reported: 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 1 of 2 for (b)(4).

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: DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6386174
• MDR Text Key: 69323404
• Report Number: 3003506883-2017-10034
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982176295
• UDI-Public: (01)10886982176295(10)H167765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 280.850
• Device Lot Number: H167765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR