MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Physical Asymmetry (4573)

Event Date 10/30/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: yen s,h., et al (2021) impact of wedge effect on outcomes of intertrochanteric fractures treated with intramedullary proximal femoral nail, j.Clin.Med.Volume 10, pages 1-10 (taiwan).This retrospective study aims to investigate (1) the risk factors for wedge effect in patients with intertrochanteric fractures (itf) treated with intramedullary (im) proximal femoral nail ii (pfna-ii), and (2) the relation between wedge effect and blade cut-out failure after pfna-ii fixation.Between january 2012 and december 2016, total of 162 consecutive patients (103 women, 59 men; mean age 79.7 years, range, 21¿95 years) sustaining itf who underwent surgical fixation using pfna-ii were assessed.113 patients (73 women, 40 men) with a mean age of 77.7 years (range, 21¿95 years) met the inclusion criteria.Nail length used were : (n=6) 170 cm, (n=23) 200 cm, (n=48) 240 cm and (n=36) long nail.The mean follow-up time was 17.3 months (range, 12¿51 months).Reported complication: the average blade position fell within the recommended optimal range, with the mean tad being 22.7 mm and the mean parker¿s ratio on ap and lateral radiographs being 49.4% and 46.4%, respectively.The mean nsa was 128.9_ for the operated hip and 133.1_ for the contralateral non-injured hip.The mean fo of the injured side after fixation using pfna-ii was 5.5 mm longer than that of the non-injured side.An average of 4.16_ of varus malalignment in nsa and 5.5 mm of femoral shaft lateralization in fo was found post-operatively.Concerning the blade position, parker¿s ratio on ap radiographs was significantly associated with the change in nsa.Parker¿s ratio on ap radiographs showed a moderate negative correlation with the change in nsa.This study demonstrated that varus change of nsa in wedge effect is significantly related to superior positioning of the blade that may increase the risk of blade cut-out.-significant difference in the presence of lateral wall fracture and postoperative varus change in nsa.3 blade cutout.This report is for an unk - nail head element: pfna-ii blade.This is report 2 of 3 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 device/unknown lot.Part and lot numbers are unknown; udi 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.

• Brand Name: UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE
• 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: 15113341
• MDR Text Key: 296690878
• Report Number: 8030965-2022-05266
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 07/27/2022
• 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): Other