MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM; APPLIANCE, FIXATION, NAIL

Catalog Number 280.850

Device Problem Fitting Problem (2183)

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

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.Due to intra-operative issues, the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing location: (b)(4).Manufacturing date: june 02, 2016.No non-conformance reports 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.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a dynamic hip screw (dhs) plate does not fit with a dynamic hip screw and condylar screw (dhs / dcs) during surgery on (b)(6) 2016.There was no prolongation of surgery and also no patient harm.There were substitute parts used to finalize the surgery successfully.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device returned to manufacturer.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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

A product investigation was performed.The dhs/dcs screw (part # 280.850) shows scratches on the surface of the shaft.The plate (part # 02.224.222) shows scratches in the boreh-hole near the positioning groove.The two noses are damaged.The measurable dimensions of the dhs-plate were as far as possible checked and found to be in compliance with the technical drawings.The bore diameter and passed.The distance between the inner parallel faces of barrel cannot be investigated, because of the damage and deformation of the two noses.The measurable dimensions of the dhs/dcs® screw were as far as possible checked and found to be in compliance with the technical drawings.The outer shaft diameter was measured and passed.The distance the parallel faces of shaft was measured and passed.Unfortunately, we only have limited information in the complaint description and cannot confirm how this happened.Based on the investigation results we can only suppose that the connection between these two parts was not aligned as intended and therefore this occurrence in combination with a mechanical overload situation could lead to the malfunction of the devices.Please note, in order to prevent such occurrence and to ensure a correct load transfer it is crucial to have an appropriate connection between the dhs-screw and the connecting screw 338.310, which is guided through the wrench 338.300.No indication for product related issue was found.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/85MM
• 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: 6241043
• MDR Text Key: 64595309
• Report Number: 3009450863-2017-10001
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982176295
• UDI-Public: (01)10886982176295(10)L016009
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

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: 280.850
• Device Lot Number: L016009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/02/2017; 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1