MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM-STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 280.000S

Device Problem Failure to Advance (2524)

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

Event Date 05/14/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Udi: (b)(4).Implant and explant dates: device malfunctioned intra-operatively and was not implanted / explanted.Initial reporter hospital contact telephone: (b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.280.000s - 9855441.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.Manufacturing location: (b)(4).Manufacturing date: 09.Mar.2016 expiry date: 01.Mar.2026 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 (b)(4) reports an event in (b)(6) as follows: it was reported during a dynamic hip screw (dhs) procedure on (b)(6) 2017, surgeon inserted the lag screw in the correct position and proceeded to slide the barrel of the plate over the screw but the plate would not advance.The lag screw was removed and it was then noted the lag screw would not insert into the plate.Another plate and lag screw were readily available and were used to complete the procedure with a delay of approximately 10 minutes and no harm to patient.Patient outcome post-operative was normal.This report is for one (1)dhs/dcs lag screw this is report 1 of 1 for (b)(6).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (dhs/dcs-scr ø12.5 l100 sst, part number 280.000s, lot number 9855441).The subject device was returned: upon visual inspection, the distal end of the screw is badly deformed, this thus confirming the complaint description.Otherwise the article is in good condition.As part of the chu investigation we have measured (the distal end) the shank diameter ø7.90 0/-0.05, and the shank width 7.15 0/-0.08 with the micrometer 3-03-17585, the result (ø7.92-8.05 / 7.24) the measurements do not meet the specifications any more.There is no particularize information what's happened to this article by customer, based on this we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.Based to this, no further investigation will be done, as raw material.No product fault could be detected.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/100MM-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: 6635167
• MDR Text Key: 77528031
• Report Number: 3009450863-2017-10015
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.000S
• Device Lot Number: 9855441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1