MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for one (1) unknown/unk - elastic nails: titanium/ part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Device available for evaluation: complainant device 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

Device report from synthes reports an event in russia as follows: this report is being filed after the review of the following journal article: popkov, a.Et al.(2022), combined lengthening for acquired leg length discrepancy: are thereadvantages of hydroxyapatite-coated intramedullary nails?, orthopaedics & traumatology: surgery & research, vol.Xx, pages 1-6 (russa).The aim of this multicenter prospective study was to analyze the outcomes of bone lengthening by external fixator associated with flexible intramedullary nailing (fin) in acquired limb length discrepancy (lld).This study included 54 patients (mean age, 17.9 years) operated on for femoral or tibial lengthening by combined technique (external fixator with fin) for acquired length discrepancy methods between january 2017 and may 2019.Titanium non-hydroxyapatite (ha)-coated fin (29 cases) or ha-coated fin (25 cases) were used.Non-ha-coated titanium nails were used in 29 patients (depuy synthes, usa, 26 patients; orthopediatrics, usa, 3 patients).Ha-coated titanium nails (orthopediatrics nails modified by metis ltd, russia) were used in 25 patients.The ilizarov frame (experimental plant of russian ilizarov scientific center ¿restorative traumatology and orthopaedics¿, russia) was used in 51 cases.Three patients were treated with the taylor spatial frame (smith & nephew, memphis, usa).The following complications were reported as follows: external migration of nail (n=1).This report is for an unknown synthes titanium nail.This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15474180
• MDR Text Key: 300558956
• Report Number: 8030965-2022-07259
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention