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

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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 blades/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available 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.

Event Description

This report is being filed after the review of the following journal article: lee y.K., et al (2022) analysis of risk factor for nail breakage in patients with mechanical failures after proximal femoral nail antirotation in intertrochanteric fractures, medicine volume 101, pages 1-5 (korea south).This retrospective multicenter study aims (1) to evaluate the frequency of implant breakage among the patients who were treated for mechanical failure after proximal femoral nail antirotation (pfna) for intertrochanteric/ pertrochanteric fracture and (2) to determine the associated factors with breakage of proximal femoral nail antirotation (pfna).From june 2005 and june 2018 at 5 tertiary referral hospitals, 35 patients underwent reoperation for mechanical complications after treatment with the pfna system for intertrochanteric/pertrochanteric fracture.Among them, 10 patients underwent reoperation due to problems not related to mechanical complications, such as surgical site infection or osteonecrosis, and thus were excluded from the study.Of the included 25 patients, there were 9 men and 16 women and the mean age at time of index surgery was 75.7±10.56 years (range 45.2¿94.0 years).Reoperations were performed at a mean of 5.4 months (range, 0.4¿13 months) after the index operation.For the index surgery, pfna with a ccd angle of 125° was used in 13 patients and that with a ccd angle of 130° was used in 12 patient.10 patients who were excluded from the study underwent reoperation due to problems not related to mechanical complications after treatment with the pfna system, such as surgical site infection or osteonecrosis.The reasons for reoperations were cutting out in 14 patients and cutting through in 4 patients.In the non-broken group with 18 patients (5 males and 13 females), conversion to hip arthroplasty was performed in 17 patients and lag screw removal was performed in 1 patient because the patient refused the hip arthroplasty.7 patients (4 males and 3 females) had reoperation due to a broken pfna at the level of the hole for the blade at average of 8 months (range, 5¿13 months) after index surgery.All implant breakages went through the proximal aperture for the helical blade.In the broken pfna group, conversion to hip arthroplasty was performed in 3 patients and osteosynthesis operation in 3 patients (fig.4).Another patient was treated conservatively because the patient refused to undergo reoperation.(a longer horizontal offset of the blade was associated with breakage of the pfna nail.All breakages of the nail went through the proximal aperture for the helical blade.) figure 4.(a) a 73-year-old man who had an intertrochanteric fracture (b) the patient underwent cephalomedullary fixation using pfna of 130° centrumcollum- diaphyseal angle (c) after 5 months, implant breakage were found (d) conversion to bipolar hemiarthroplasty was performed.( a longer horizontal offset of the blade was associated with breakage of the pfna nail.All breakages of the nail went through the proximal aperture for the helical blade.) this report is for unknown synthes proximal femoral nail antirotation (pfna) blade.This report captures the reported 73-year-old man who after 5 months had implant breakage (moreover, a longer horizontal offset of the blade was associated with breakage of the pfna nail.All breakages of the nail went through the proximal aperture for the helical blade.) a copy of the literature article is being submitted with this medwatch.This is report 7 of 7 for (b)(4).

• 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: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15135885
• MDR Text Key: 296951666
• Report Number: 8030965-2022-05438
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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: 07/05/2022
• 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