MAUDE Adverse Event Report: SYNTHES (USA) 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/340MM/RT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.003.248S

Device Problem Failure to Align (2522)

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

Event Date 03/06/2016

Event Type  Injury  

Manufacturer Narrative

Patient identifier and weight are unknown.Udi number: (b)(4).D6/d7: per the event description, it is unlikely that this device was implanted during the procedure.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: may 30, 2014 - expiration date: april 30, 2023.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 sterility documentation was reviewed and determined to be conforming.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.

Event Description

It was reported that a patient underwent a surgical procedure on (b)(6) 2016 in order to treat a midshaft femur fracture resulting from a vehicle accident.During the procedure, the surgeon noted that the aiming arm missed the screw holes proximally.An attempt was made laterally to medial static the screw hole, but the drill bit missed the screw.The screw was removed and an alternate screw (120-degree) was inserted, but the same result was achieved.The surgeon was unable to lock the nail proximally, but was successful in achieving distal locking.The procedure was prolonged by thirty (30) minutes due to the intra-operative alignment issue.This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Implant date added as the nail was implanted, but the screws had insertion difficulties due to misalignment.Device was not explanted.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: 9MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/340MM/RT-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1051-1101 synthes ave.; monument CO 80132
• Manufacturer (Section G): SYNTHES (USA); 1051-1101 synthes ave.; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5523638
• MDR Text Key: 145298607
• Report Number: 1719045-2016-10250
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 04.003.248S
• Device Lot Number: 7608323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2016
• Initial Date FDA Received: 03/24/2016
• Supplement Dates Manufacturer Received: 03/24/2016
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR