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

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for an unk - constructs: pfna/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 as no product was received.The investigation could not be completed and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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: zhang y., hu j., li x., qin x., (2020) reverse wedge effect following intramedullary nailing of a basicervical trochanteric fracture variant combined with a mechanically compromised greater trochanter, bmc musculoskeletal disorders volume 21, pages 1-9 (china).This study aims to investigate the incidence of the ¿reverse wedge effect¿ at a level-one tertiary trauma center, summarize its morphological features and analyze its cause and potential influence on treatment outcomes.Between january 2013 and january 2017, a total of 414 tf cases that underwent in fixation were included in this study.A total of 33 patients (12 males,21 females) , with mean age of 72.5 years (33 to 96 years) met the inclusion criteria.Thirty-one patients were stabilized by proximal femoral nail anti-rotation (pfna, synthes inc., oberdorf, switzerland) and two younger patients by a trigen intertan nail (smith¿nephew, memphis, usa).The following complications were reported: overall incidence of the ¿reverse wedge effect¿ was 7.9%.Internal rotation of the cephalopelvic fragment and inferior.Opening at the basicervical fracture line caused by nailing a satisfactorily reduced tf.Varus malreduction presented as a secondary fracture displacement caused by inserting a cephalate in from the tip of the gt.The internal rotation of the cephalopelvic fragment caused by reamer/in impingement was the main underlying cause of this intraoperative complication.On the postoperative radiograph, this secondary displacement demonstrated an inferior gap at the primary fracture line and increased nsa.The simulated diagram depicting the ¿wedge effect¿, where the intramedullary nail insertion causes lateralization of the femoral shaft and varus malalignment.The preoperative anteroposterior (ap) radiograph showing an apparently simple ao-31a1.3 (2018 version) pertrochanteric fracture.B following fixation with pfna, there was an obvious inferior gap at the basicervical region (white arrow) and moderate valgus deformity.A and b preoperative 3d image demonstrating a subtype 4-fragmentary gl pertrochanteric fracture with mild varus deformity.C and d the wide arrow indicate the impact between the reamer and the superolateral cortex of the cephalopelvic fragment.This report is for an unknown synthes pfna.This report is for (1) unk - constructs: pfna.This report is 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11440737
• MDR Text Key: 239067286
• Report Number: 8030965-2021-01728
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• 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: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention