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

Catalog Number 280.100S

Device Problem Fitting Problem (2183)

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

Event Date 12/18/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Other number¿udi: (b)(4).Implant and explant dates: due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.Initial reporting facility phone number is (b)(6).The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: oct 2, 2014.Expiration date: sep 1, 2024.One non-conformance record (ncr) was generated during production.This ncr documented that four parts were removed from this lot.This has no influence on the reported issue.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 (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery the dynamic hip system (dhs) screw did not fit in the dhs plate.There was no additional information available regarding the reported event; however, there was no report of patient harm or surgical delay.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the investigation of the dhs/dcs screw has shown that the positioning groove of the screw is damaged due to an inadequate handling.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 led to the deformation of the screw.Per the surgical technique literature, 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.The visual inspection of the returned lcp dhs plate has shown some damages at the edges of hole were the screw is inserted.There were no other damages detected.A functional test was performed with an available dhs/dcs screw.It was found that the screw could be inserted into the plate without any problems.The device history record of both items were researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.No product fault could be detected.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/110MM-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: 6271814
• MDR Text Key: 65576534
• Report Number: 3009450863-2017-10002
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2017

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: 280.100S
• Device Lot Number: 9154690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1