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

Device Problem Migration (4003)

Patient Problems Arthritis (1723); Bone Fracture(s) (1870); Necrosis (1971); Non-union Bone Fracture (2369); Insufficient Information (4580)

Event Type  Injury  

Event Description

Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article: larose, g., tufescu, t., and graham, c.(2022), periprosthetic fracture rate after short and long hip nails: analysis of a regional health database, injury, vol.53, pages 2195-2198 (canada).The purpose of this study was to review the periprosthetic fracture rate after cephalomedullary nailing of patients with in- tertrochanteric fractures in winnipeg with both short and long nails.From june 2009 to december 2017, a total of 970 patients were treated with the trochanteric fixation nail (tfn) (depuy synthes, united states of america) and the gamma3 (stryker, united states of america).315 patients were treated with a long nail and 655 patients with a short nail.There were 178 males and 477 femails in the short nail group while there were 108 males and 207 females in the long nail group.The article does not provide sufficient information to identify which device manufacturer is associated with the adverse event.The following complications were reported as follows: the in-hospital mortality was 4.4% in the long nail group and 3.8% in the short nail group ( p = 0.64).The one-year mortality was 17.7% in the long nail and 21.6% in the short nail group ( p = 0.19).The person-year mortality was 1079.5 person-years in the long nail group and 1976.1 person- years in the short nail group.Causes for revision: long nail, periprostehtic fracture (n=4), hardware irritation (n=4), cut out (n=3), osteoarthritis (n=1), non-union (n=5).The average refracture was at 1103 days post op: 1 patients sustained an intra-operative fracture, revision surgery included 2 cases treated with revision to a plate construct and 2 cases of long nail exchanges.Short nail: periprostehtic fracture (n=16), hardware irritation (n=1), cut out (n=13), osteoarthritis (n=4), non-union (n=1), avascular necrosis/head collapse (n=2).The average refracture was at 447 days post op: 11 out of the 16 patients were treated with a conversion to a long nail, 3 with plate fixation and with nail retention, while 2 were treated non-surgically.This report is for an unknown synthes tfn.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.510k: this report is for an unknown constructs: tfn/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.

• Brand Name: UNK - CONSTRUCTS: TFN
• 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: 15094362
• MDR Text Key: 296492113
• Report Number: 8030965-2022-05135
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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