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

Device Problem Migration (4003)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown nail head elements: pfna blade/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.

Event Description

This report is being filed after the review of the following journal article: law, g.W., koh, j.S.B., yew, a.K.S., and howe, t.S.(2020), scanning electron microscopy study of retrieved implants suggests a ratcheting mechanism behind medial migration in cephalomedullary nailing of hip fractures, malaysian orthopaedic journal, vol.14 (1), pages 7-17 (singapore).The aim of this study is to further investigate the medial migration phenomenon and the proposed ratcheting mechanism by studying retrieved implants from patients who have undergone revision surgery as a result of the medial migration phenomenon.A total of 4 patients, with prior fixation of their pertrochanteric hip fractures with the synthes proximal femoral nail antirotation (pfna), who underwent revision surgery were included in the study.The mean follow-up was unknown.The following complications were reported as follows: group with medial migration: patient 1: a chinese female underwent revision surgery for a femoral head perforation with fne penetration into acetabulum.Patient 2: a chinese male patient underwent revision surgery for a femoral head perforation with fne penetration into hip joint.Group without medial migration: patient 3: a chinese female patient underwent revision surgery for a femoral head perforation with fne penetration into acetabulum.Patient 4: a chinese male patient underwent revision surgery for a femoral head perforation with fne penetration into acetabulum.This report is for an unknown synthes pfna blade.

• Brand Name: UNK - NAIL HEAD ELEMENTS: PFNA BLADE
• 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: 11386398
• MDR Text Key: 241463203
• Report Number: 8030965-2021-01409
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 02/04/2021
• 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