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

Device Problem Migration (4003)

Patient Problems Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Malunion of Bone (4529); Physical Asymmetry (4573)

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.This report is for an unknown nails: pfna/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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

Device report from synthes reports an event in india as follows: this report is being filed after the review of the following journal article: chahar h., jafri m.A., gopal p., thulasidharan v.P., (2022) a comparative study of functional outcome of intertrochanteric fractures operated with pfna and intertan in a tertiary care center, the journal of international medical sciences academy, vol 35; no.1, pages 1-7 (india).This study aims to compare the short-term clinical outcomes of unstable intertrochanteric fractures managed with intertan and pfna.There are 40 patients who underwent the study included 23 males and 17 females.Their age ranged from 50-70 years.In post-operative period, the patients were reviewed at 2 weeks, 1 month, 3 months, 6 months and 12 months by the operating surgeon.Reported complication: one patient had superficial wound infection.He underwent wound debridement and was discharged on 10th post operative day after healthy healing; 1 nonunio; 1 fracture of lateral cortex; 1 fracture displacement at nail insertion/lateral greater trochanteric fracture; varus mal-union, shortening 2cm; 1 poor functional score according to harris hip score; 3 fair functional score according to harris hip score; 1 cut out proximal screws.This report is for unknown synthes pfna.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - NAILS: PFNA
• 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: 15096241
• MDR Text Key: 296515939
• Report Number: 8030965-2022-05148
• 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: 07/25/2022
• 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: 06/27/2022
• 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