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

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

Patient Problems Non-union Bone Fracture (2369); Reaction (2414)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown pfna constructs/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.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: tucker a., et al (2018) fatigue failure of the cephalomedullary nail: revision options,outcomes and review of the literature,european journal orthopaedic surgery and traumatology volume 28(3), pages 511¿520 (united kingdom).This study primarily aims to assess the incidence of mechanical failure of the cmn device, characterize their mechanical failure and report their revision surgery with 12-month outcomes and mortality.Between 1 january 2000 and 31 december 2015, a total of 27,055 had hip fracture.A total of 50 patients underwent cmn revision.The case review resulted in 30 exclusions.The remaining 20 patients, with a 3:1 female preponderance, mean age at primary surgery of 73 ± 15.24 years (median age 72 years) were included in the study.The included cases comprised a mixture of long gamma nails (stryker ltd, (b)(4)) and proximal femoral nail, antirotation (pfna) devices (synthes ltd, (b)(4)).Overall clinical follow-up post-revision was an average of 338.0 ± 271.95 days.The following complications were reported as follows: the presence of the lag screw outside the lateral wall was present in 11/20 of cases.Contact fixation with the trochanteric entry point was present in 12/20 of cases.3 out of the 20 cases had a poor grade according to the quality of reduction.Radiographic non-union in 1 case (at > 3.5 years post-operatively).8 cases with fatigued cmns had revision to im nail.6 cases with fatigued cmns had revision to proximal femoral locking plate.(cases that went on to have had a further revision procedure: 2 pflp revisions due to metalwork revision surgery which subsequently united, whilst the other was converted to an endoprosthesis.) 3 cases with fatigued cmns had revision to arthroplasty.3 cases with fatigued cmns had revision to endoprosthesis.Mortality rates in revision nails 2/8 cases.Mortality rates with revision to proximal femoral locking plate 2/6 cases.Overall mortality at 12 months was 6/20 cases.1 removal of cmn for cut out in which the fracture had united(cases that went on to have had a further revision procedure).This report is for an unknown synthes proximal femoral nail antirotation (pfna) construct.It captures the reported events of contact fixation with the trochanteric entry point was present in 12/20 of cases, 3 out of the 20 cases had a poor grade according to the quality of reduction and radiographic non-union in 1 case (at > 3.5 years post-operatively).This is report 2 of 4 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9721054
• MDR Text Key: 192150033
• Report Number: 8030965-2020-01203
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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: 02/06/2020
• 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