MAUDE Adverse Event Report: SYNTHES BALSTHAL TI DHS®/DCS® LAG SCREW 12.7MM THREAD/75MM; APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 480.750S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient information is unknown.Unknown when infection started; it was noted on (b)(6) 2015.(b)(4).Device has not been explanted.(b)(6).Manufacturing location: (b)(4).Manufacturing date: 13december2013.Expiry date: 01december2023.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: it was reported the surgery for femoral trochanteric fracture was performed on (b)(6) 2015; dynamic hip system (dhs) implants were applied.On (b)(6) 2015, it was reported a postoperative infection was noted on the patient.The devices are currently still implanted in the patient.This is report 2 of 6 for (b)(4).

• Brand Name: TI DHS®/DCS® LAG SCREW 12.7MM THREAD/75MM
• Type of Device: APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
• 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: 5304046
• MDR Text Key: 33699628
• Report Number: 3009450863-2015-10032
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK953607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/30/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: 480.750S
• Device Lot Number: 8759427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention