MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/75MM-STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 280.750S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(b)(4).Device was not implanted or explanted complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing site: (b)(4), manufacturing date: 20.June 2016, expiry date: 01.June 2026.A pd event evaluation was performed with following conclusion.The affected products have not been returned and no x-rays have been provided, therefore, no incontestable statement can be done and the complaint is rated as ¿not confirmed¿ if the compression screw head is contacting the dcs/dhs screw instead of the dcs plate shoulder then no compression can be achieved.This may occur if the screw is not inserted deep enough or if the screw is chosen too long.However: the risk management document does adequately address the reported issue and the product can be considered as safe and efficient 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

Device report from synthes europe reports an event in the (b)(6) as follows: it is reported surgeon attempted to implant patient with the dynamic compression system (dcs) plate on (b)(6) 2017 but was unable to obtain compression.The 75 mm lag screw was inserted and the dcs plate was placed over it.The compression screw did not compress.It is further reported it appeared as the lag screw was too long to allow the compression.The plate and screw were removed and an alternate implant was used.Procedure was completed successfully with a delay of approximately 1 hour.Concomitant devices reported: dcs plate (part 281.900s, lot 8969679, quantity 1), dhs/dcs compression screw (part 280.990s, lot l010745, quantity 1).This report is for one (1) dhs/dsc lag screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).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/75MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6497525
• MDR Text Key: 72918832
• Report Number: 3009450863-2017-10008
• Device Sequence Number: 1
• Product Code: KTT
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.750S
• Device Lot Number: L023790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: COMPRESS SCREW (280.990S, LOT L010745, QTY 1); DCS PLATE (281.900S, LOT 8969679, QTY 1)
• Patient Outcome(s): Required Intervention