MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: PFN; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: mukherjee, k., prashanth, t., thirunthaiyan, m.R., and kumar, d.(2022), mismatch of short straight proximal femur nails with anterior bow of femur in indian population- a radiological and functional analysis, journal of orthopaedics, vol.29, pages 65-70 (b)(6).The aim of the study is to determine the degree of mismatch, determine the extent of anterior encroachment by the nail tip and the possible measures to avoid them in indian population.From 2019 to 2021, 80 patients with trochanteric fractures (ao 31a2 and 31a3) were treated with a short pfn.All fractures were fixed with pfns, with nails ranging from 170 to 250 mm.There were 41 males and 39 females with a mean age of 68.17 years ± 9.6, with patients in the age ranging from 43 to 80 years.The following complications were reported as follows: 16 patients had ntp grade 3.9 patients had ntp grade 4.20 patients complained of anterior thigh pain on follow-up at 6 months.*grade 3 - nail contact ranging from one third to two third of anterior cortex *grade 4 - nail has more than anterior two third contact of the femur cortex this report is for an unknown synthes pfn.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

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 an unknown nails: pfn/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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.

• Brand Name: UNK - NAILS: PFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 15105929
• MDR Text Key: 296612457
• Report Number: 8030965-2022-05209
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/26/2022
• 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: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention