MAUDE Adverse Event Report: SYNTHES ELMIRA DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR.

Catalog Number 280.295

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional product code: ktt.Udi: (b)(4).Lot number unknown.Explant is scheduled for (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 Description

It was reported that a revision is scheduled for (b)(6) 2018 due to malunion of the right femur.The original procedure to repair a pertrochanteric right hip fracture with a dynamic hip screw (dhs) construct was performed on (b)(6) 2011.Subsequently, the malunion was discovered.Device related malfunction is not reported.This report is for one (1) dhs/dcs one-step lag screw 12.7 mm thread 95 mm.This is report 2 of 7 for com-(b)(4).

Manufacturer Narrative

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 Description

Update: 1-15-18 - reopened, revision performed on (b)(6) 2018.The hardware was removed and converted to a total hip arthroplasty.No complications regarding removal of hardware were reported.

• Brand Name: DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR.
• 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: 7037061
• MDR Text Key: 92197374
• Report Number: 3003506883-2017-10265
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964259
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 280.295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention