MAUDE Adverse Event Report: SYNTHES SELZACH 13MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/380MM/RT; N/A

Catalog Number 04.003.656S

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

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient id case# (b)(6).(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was conducted.The report indicates that the: manufacturing location: (b)(6), manufacturing date: 20-may-2013.Part #: 04.003.656, lot#: 7390280 (non-sterile) - 13mm ti lateral entry femoral recon nail-ex/380mm/rt.Quantity (b)(4).No ncrs 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.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 patient underwent revision for intramedullary nail removal on (b)(6) 2016, due to non union of sub trochanteric fracture.One lateral entry femoral nail, two 6.5 mm recon screws and two 5.0 mm distal locking screws were removed successfully without delay.Surgeon utilized synthes 95 degree blade plate and unknown quantity of 4.5 mm cortex screws to repair the fracture and procedure was completed successfully and patient was reported as stable post operatively.All the explanted devices were intact and not broken.Date of original implant was (b)(6) 2016.This complaint involves 3 devices.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Device was used for treatment, not diagnosis expiration date added.(b)(4).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.No ncrs were generated during production.Part #: 04.003.656, lot#: 7390280 (non-sterile) - 13 mm ti lateral entry femoral recon nail-ex/380 mm/rt.Quantity 6.Manufacturing location: (b)(4), manufacturing date: 20-may-2013.Please note, this dhr review is for sterilization procedure only: 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.No ncrs were generated during production.Manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 24.Jun.2013, expiry date: 01.Apr.2022.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 13MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/380MM/RT
• Type of Device: N/A
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CO CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CO CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6156658
• MDR Text Key: 61849519
• Report Number: 1719045-2016-10899
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040336
• 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,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: 04.003.656S
• Device Lot Number: 7390280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68