MAUDE Adverse Event Report: SYNTHES ELMIRA DHS®/DCS® LAG SCREW 12.7MM THREAD/110MM; APPLIANCE,FIXATION,NAIL

Catalog Number 280.100

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2014

Event Type  malfunction  

Manufacturer Narrative

Additional 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.

Manufacturer Narrative

Additional narrative: product investigation: product drawing from time of manufacture was reviewed during this evaluation.No drawing discrepancies were identified.The dynamic hip system ¿ general / dhhs design document adequately addresses the complaint condition: ¿does not/will not function: functional issue, unspecified¿.Specifically, the function ¿compatibility of instruments with implants,¿ with a hazard of ¿the system cannot be used as intended.¿ the lag screw was complained for the tip of the broken coupling screw being stuck in the threads.This had no bearing on the design of the lag screw.The design is adequate for its intended use and did not contribute to this complaint condition.The complaint is confirmed.Device 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 when lag screw was screwed into the dynamic hip and condylar screw system (dh/dcs) coupling short screw, the thread of the dhs coupling screw broke off inside the dhs lag screw.No patient harm was reported.Back-up lag screw was used to complete the surgery successfully without any surgical delay.Per additional information, all fragments were inside lag screw and the incident occured on the back-table.A back-up coupling screw was used to complete the surgery.This is 1 of 2 reports for (b)(4).

Manufacturer Narrative

Device used for treatment not diagnosis.The part has been received; an evaluation is in progress.A review of the device history record did not reveal conditions that could have contributed to the reported event.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/110MM
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4378097
• MDR Text Key: 12771153
• Report Number: 3003506883-2015-10003
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.100
• Device Lot Number: 6265493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 01/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/23/2015; 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 39 YR