MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM-STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 280.900S

Device Problem Fitting Problem (2183)

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

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).Device history records review was conducted.The report indicates that the: 280.900s / 9233942.Manufacturing location: (b)(4).Manufacturing date: 12.Nov.2014 expiry date: 01.Nov.2024.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 procedure on (b)(6) 2017, a male patient, victim of a scooter accident, presenting with a subtrochanteric fracture of the left femur.It was not possible to implant the dynamic hip system (dhs) screw.The screw did not fit into the plate.They used the same screw from a different lot to complete the procedure.The surgery was prolonged about 15 minutes.No information available about patient condition and outcome.There was no patient harm and no fragments were generated.This complaint involves 1 part.Concomitant reported part: 1x unknown dhs plate.This report is 1 of 1 for com-(b)(4).

Manufacturer Narrative

Patient id was not provided for reporting.The device was 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

Product development investigation was completed.The investigation summary indicates that the: received part: 1 x 280.900s/dhs/dcs-scr ø12.5 l90 sst/lot no.9233942.Our investigation has shown that the positioning groove of the screw is expanded and damaged.The manufacturing review shows that the production procedure was per the specifications and there were no issues that would contribute to this complaint condition.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 ao/asif specification.The outside diameter with tolerance dimension of max.And min.Amounts was measured with the dimension result and passed, therefore, the required dimension is successful according drawing.The measurement occurred with micrometer, 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 have led to the complaint condition.This relation to the surgical technique: ¿warning: to avoid damaging the instruments and the implant, tighten the connecting screw securely.¿ noted, 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 product fault could be found.Finally, we conclude that the cause of failure is not due to any manufacturing non-conformance's.No product fault could be detected.Device 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/90MM-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: 6952366
• MDR Text Key: 90563097
• Report Number: 3009450863-2017-10030
• 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,Followup
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.900S
• Device Lot Number: 9233942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 65