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

Catalog Number 280.950S

Device Problem Fitting Problem (2183)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient information not provided by reporter.(b)(4).This event resulted in the need for position change to the patient while under anesthesia.Additionally, this patient had to be converted to a prosthesis.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4).Manufacturing date: 28 october 2015.Expiry date: 01 october 2025.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the 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 it was impossible to slide the dhs plate onto the cephalic screw intraoperatively.Another plate was used but the same problem happened again.Surgeon was unable to extract the cephalic screw with the extractor.Clinical consequences were to change the operative position during the surgery where there is an increase risk of infection and the risk of falling, by passing the fracture table in the lateral position and obligation to convert intermediate prosthesis.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

(b)(4).Device was not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

It was reported that the surgery was prolonged about one hour.

Manufacturer Narrative

Product investigation summary: the positioning groove of the dhs/dcs screw is expanded and damaged.There are several forceps marks, or that from a similar instrument, at the end of the shaft visible.The dimensions of the dhs-screw cannot be investigated due to the damage and deformation.The device history record reviews for all involved devices shows that the correct materials and manufacturing procedures were used.The examination of the raw-material testing certificates showed no deviations regarding material analysis, strength, and/or structural stability.The values were in compliance the international standards for stainless steel.Based on the investigation results, and the received information, the exact root cause of the event cannot be determined.Due to the wear and tear signs at the screw, it is likely that the connection between the wrench and the screw was not aligned as intended, resulting in this occurrence in combination with a mechanical overload situation leading to the complained event.In this relation, it is important to point out that the surgical technique guide warns the user to avoid damaging the instruments and the implants, by tightening the connecting screw securely.Please note, in order to prevent such occurrences as described, and to ensure a correct load transfer, it is crucial to have an appropriate connection between the dhs-screw and the connecting screw, which is then guided through the wrench.No product fault could be found.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/95MM-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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5464375
• MDR Text Key: 39194179
• Report Number: 3009450863-2016-10005
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791619
• 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: 02/08/2016

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: 280.950S
• Device Lot Number: 9697656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/18/2016; 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR