MAUDE Adverse Event Report: SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 34MM; NAIL, FIXATION, BONE

Catalog Number 459.340

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

Patient Problems Muscle Weakness (1967); Reaction (2414); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information was not provided by reporter.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.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) reported an event in (b)(6) as follows: it was reported that the patient experienced numbness and weakness of her leg and the inability to eat noodle, milk, egg, and bread products approximately 20 months post-operatively.The patient was examined at the hospital and testing indicated that she is allergic to titanium.The patient is not suffering from skin irritation.Explantation of all the indwelling devices which include a proximal femoral nail and associated hardware was suggested.The patient refused revision surgery because of potential surgical risks.The patient originally underwent implantation surgery on (b)(6) 2013 to treat injuries sustained during a traffic accident.The initial surgery is successful and no abnormalities during the procedure.This report is 1 of 4 for (b)(4).

• Brand Name: 4.9MM TI LOCKING BOLT 34MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5251163
• MDR Text Key: 32166694
• Report Number: 3009417901-2015-10035
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 11/10/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 459.340
• Device Lot Number: 5920518
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention