MAUDE Adverse Event Report: SYNTHES GMBH 16MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.003.953

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

Patient Problem Non-union Bone Fracture (2369)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

This report is being filed after the review of the following journal article: freischmidt h., et al (2020) : individualized techniques of implant coating with an antibiotic-loaded, hydroxyapatite/calcium sulphate bone graft substitute, therapeutics and clinical risk management volume 16 , pages 689¿694 (germany) http://doi.Org/10.2147/tcrm.S242088.This study presents a case report of patients to provide three new surgical techniques to coat different implants with an antibiotic-loaded, hydroxyapatite/calcium sulphate bone graft substitutes in order to address the heterogeneity of both microorganism and surgical site.A case of a (b)(6) year-old male patient fractured his left femur shaft.Initially, it was treated on site with an intramedullary nail.One year later the patient still suffered from pain due to a non-union.A resection of the non-union and the left femur was performed and was immobilized with an external transport fixator as there was a significant shortening of the leg.An infected non-union was diagnosed and a mrsa could be intraoperatively isolated from the non-union site.A bone lengthening was approached for 2 months via the external fixator.The lengthening failed and even though a rigid external fixator was subsequently applied for another 6 months, no bone healing could be achieved.Metal removal and complete en bloc resection of the non-union was done and a vancomycin loaded cement spacer was inserted intramedullary.As a next step, the cement spacer was removed and a nail osteosynthesis was inserted after the medullary canal had been reamed (lfn 360/16 mm, fa synthes).Before insertion, the nail was augmented with cerament v.After the procedure an intravenous treatment with vancomycin was done.At this time he did not have pain in the area of non-union and progressing, still incomplete bone healing could be detected in the ct scan.Finally, two years after the accident, the nail was dynamically locked for dynamic compression of the nonunion.Full weight bearing of the left lower extremity was possible immediately.After 22 months a complete bone healing was achieved.(case 2) a case of a (b)(6) year-old female patient presented with a loosening of a proximal humeral nail (phn, fa.Synthes) after fractured left humeral head due to a fall on her shoulder.As reason for the loosening, an infection with extensive abscess formation around the implant was identified.The situation was complicated by the patient¿s incompliance and comorbidities such as schizophrenia.The osteosynthesis was removed and a gentamicin and vancomycin loaded cement spacer was implanted.During the second revision the shoulder joint was macroscopically free of infection, and thus an implantation of an inverse shoulder prosthesis was done (fa synthes depuy) seven weeks later.Fifteen months after implant coating of the shoulder prosthesis with cerament v there were no signs for a recurrence of the infection.This report is for an unknown synthes lfn 360/16 mm and unknown synthes proximal humeral nail.This report is for one (1) 16mm ti lateral entry femoral recon nail-ex/360mm/lt-sterile.This is report 1 of 3 for (b)(4).

• Brand Name: 16MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/360MM/LT-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12586711
• MDR Text Key: 275130227
• Report Number: 8030965-2021-08450
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819780385
• UDI-Public: (01)07611819780385
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.003.953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention