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

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

Patient Problems Bone Fracture(s) (1870); 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.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 constructs: pfna-ii/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device avilable for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: 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 (b)(6) as follows: this report is being filed after the review of the following journal article: song, h.Et al.(2021), sub-classification of ao/ota-2018 pertrochanteric fractures is associated with clinical outcomes after fixation of intramedullary nails, geriatric orthopaedic surgery & rehabilitation, volume 12, pages 1¿6 (b)(6).This research was conducted to investigate the impact of the fracture classification in pertrochanteric fractures on outcomes and mechanical complications.From january 2017 to may 2020, 154 patients (48 males and 106 females) diagnosed with pertrochanteric fractures were treated with pfna-ii (proximal femoral nail anti-rotation).The following complications were reported as follows: 13 patients had varus displacement.10 patients had excessive lateral sliding.This report is for an unknown synthes pfna-ii.A copy of the literature article is being submitted with this medwatch.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA-II
• 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: 15105473
• MDR Text Key: 296606652
• Report Number: 8030965-2022-05201
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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?: No
• 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