MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/95MM; APPLICANCE, FIXATION, NAIL

Catalog Number 280.950

Device Problem Fitting Problem (2183)

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

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id, dob & weight not available for reporting.Device not explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that the: part #280.950 / lot #9340262.Manufacturing location: (b)(4).Manufacturing date: 23.Jan.2015.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.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 on an event in (b)(6) as follows: it was reported that during an intervention, the dynamic hip system plate (dhs) did not slide over the implanted dhs screw.The screw had to be replaced with a new one that slid this time perfectly.The surgery was prolonged to an unknown time.No information available about patient condition and outcome.The procedure was successfully completed as another screw was used.Patient outcome is fine.This complaint involves 1 part.Concomitant reported part: 1x unknown dhs plate.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the device was received with the positioning groove of the dhs/dcs screw expanded and damaged.The measurable dimensions of the dhs/dcs screw were as far as possible checked and found to be in compliance with the technical drawings and specifications.The outside diameter was measured and passed.Because of the damage the slot dimension was not measurable.Our investigation has shown that the positioning groove of the screw is expanded and damaged.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.It is likely that the connection between the wrench and the screw was not aligned as intended and therefore this occurrence in combination with a mechanical overload situation could lead to the complaint condition.No product fault could be found.Finally we conclude that the cause of failure is not due to any manufacturing non-conformances.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

The device has been received and the product evaluation is in progress.No conclusion can be drawn.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.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/95MM
• Type of Device: APPLICANCE, 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: 6818184
• MDR Text Key: 83748301
• Report Number: 3009450863-2017-10026
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819012738
• UDI-Public: (01)07611819012738(10)9340262
• 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,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.950
• Device Lot Number: 9340262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 62 YR