MAUDE Adverse Event Report: SYNTHES BALSTHAL TI DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 480.900

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Event Description

This is report 4 of 5 for (b)(4).

Manufacturer Narrative

Additional 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.

Manufacturer Narrative

Additional narrative: 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.

Manufacturer Narrative

Additional narrative: a product investigation was completed: we have received these articles 3009450863-2015-10010, 480.990s, 480.900, 414.834 back in an intact condition.Our investigation of the complained implants has shown: that the articles 414.838, 414.838, 414.836 we have received back broken / badly damaged and one with bone adhered.Also there are scratches on the surface and deformation at shank and at the thread visible.This indicates contact with the plate.We are not able to determine the exact reason for this reported problem, but it is likely that during the operation an application error may have taken place or that an overloading situation or strong body / bone movement from the patient led to these breakages of the screws.The manufacturing records were reviewed the implants were manufactured in (3009450863-2015-10010, 8612986, september 2013; 480.990s, 8753610, december 2013; 480.900, 8903215, may 2014; 414.834, 8633444, september 2013; 414.838, 2452548, january 2009; 414.838, 9019617, june 2014; 414.836, 8590497, august 2013), produced to specification and met all release criteria.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.(b)(4).

Manufacturer Narrative

The initial complaint was reviewed and found not reportable.There is no documentation of this event causing or contributing to an injury.There is no documentation of fragmentation of the complaint device.There is no documentation of this event causing or contributing to a surgical delay.Rationale: not likely to result in patient harm or the need for additional medical or surgical intervention, and no history of a previous report of serious injury or death.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 (b)(4) reports an event in (b)(6) as follows: the reported three cortex screws were found broken post-operatively.The reported products were used for femoral trochanteric fracture.The initial implant date was (b)(6) 2014.The surgery of explant and re-fixation with another manufacturing¿s products was performed on (b)(6) 2015.Varus deformity was confirmed after the initial surgery.It was reported the plate was not broken this is report 2 of 3 for (b)(4).

Manufacturer Narrative

Event date: unknown.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was completed: lot number provided correspond to the non-sterile version of part number provided.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.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: TI DHS®/DCS® LAG SCREW 12.7MM THREAD/90MM
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4623171
• MDR Text Key: 5759175
• Report Number: 3009450863-2015-10010
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/10/2015

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: 480.900
• Device Lot Number: 8903215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/23/2015; 03/25/2015; 04/15/2015; 06/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention