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

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: cho, h.M., park, j.Y., kwon, k.H., and lee, y.(2021), is it advantageous to use the intraoperative compression option of proximal femoral nail antirotation in the treatment of osteoporotic intertrochanteric fractures? a retrospective comparative study, acta orthopaedica et traumatologica turcica, vol.55(4), pages 285¿292 (south korea) the aim of this study was to retrospectively compare the radiological and clinical results of intertrochanteric fractures treated with proximal femoral nail antirotation (pfna) that were either intraoperatively compressed or non-compressed.Between january 2015 and december 2017, 94 patients (64 female, 30 male; mean age = 77.6 years; age range = 68¿81) underwent intraoperative fracture compression (iofc) (94 hip joints, group a) and 88 patients (64 female, 24 male; mean age = 77.1 years; age range = 67¿80) who underwent postoperative impaction (poi) alone (88 hip joints, group b).All of these patient were treated with a pfna.The mean follow-up was 38.4 (range = 24-48)months in group a and 36.7 (24-48) months in group b.The following complications were reported as follows: group a: 1 patient required revision surgery for hematoma.The drain was withdrawn on the day of surgery by a patient who developed delirium, and the surgical site became tight and tensioned.This patient had a large subcutaneous hematoma at the site of the fall, and a drain was inserted.Three days after the operation, the drain was reinserted and the hematoma improved.Group b: 1 patient underwent a free-handle technique insertion under fluoroscopy because the target device became loose during surgery and the distal fixation screw direction did not match.1 patient had nonunion.Compression of the fracture interval didnot reduce until3months after the operation, and nail breakage occurred in the blade insertion area of the nail at 5 months; thus, the nail was changed to long pfna combined with iofc, and complete union was achieved 5 months after reoperation.This report is for an unknown synthes pfna nail.This is report 3 of 4 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 pfna nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device avilable for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 - NAILS: PFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15108311
• MDR Text Key: 296656002
• Report Number: 8030965-2022-05230
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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: 06/28/2022
• 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): Required Intervention