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

Catalog Number 280.850S

Device Problem Fitting Problem (2183)

Patient Problems Sedation (2368); No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: 280.850s / 9836766, manufacturing location: (b)(4), manufacturing date: 25.Feb.2016.Expiry date: 01.Feb.2026.No anomalies were detected during device history record review.No ncrs were generated during production.Review of the device history record 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 installation of the screw, the plate, previously mounted on the screw-plate holder, has not slid on the smooth part of the screw.Delay in surgery but unknown how many minutes.The surgery was successfully completed.This complaint involves 2 parts.This report is 1 of 2 for com-(b)(4).

Manufacturer Narrative

Initial reporter hospital contact number: (b)(6).Product investigation summary: the following devices were received for evaluation: part 280.850s / lot 9836766 and part 02.224.202s / lot 9681109.The positioning groove of the dhs/dcs screw is expanded and damaged while the plate shows scratches all over the surface.The threaded bore near to the barrel is 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, with a maximum tolerance dimension of 8.06mm and a minimum of 7.97mm, was measured with the dimension result of 8.00mm (passed).Also, the distance 7.20 0/+0.1mm between the inner parallel faces of the barrel was found to be within the specifications (7.24mm).The outer diameter of the dhs-screw 7.9 0/-0.05 was measured with a passing dimension of 7.88mm.The distance of the outer surfaces of 7.15 0/-0.08 with the measured dimension of 7.10mm.Further analysis cannot be investigated due to the present damages and deformations.The device history records for both devices were reviewed.It was noted that both devices were produced according to the specifications with no issues identified that would have contributed to this complaint condition.Unfortunately, the manufacturer cannot confirm the exact root cause for the issue as only limited information was provided.Based on the investigation results, it is most likely that the connection between the wrench and the screw was not aligned as intended.This occurrence, in combination with a mechanical overload situation, likely led to the malfunction of the devices.Please note: in order to prevent such occurrences, and in order to ensure a correct load transfer, it is crucial to have an appropriate connection between the dhs-screw and the connecting screw.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.

Manufacturer Narrative

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

Additional information was received on august 3, 2016 reporting that the surgical delay due to the reported event was ¿significant¿ and there is concern regarding this delay resulting in an increased risk of infection.The exact duration of the surgical delay is still unknown.

• Brand Name: DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM-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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5826196
• MDR Text Key: 50555619
• Report Number: 3009450863-2016-10020
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.850S
• Device Lot Number: 9836766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/17/2016; 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention