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

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: halonen, l.M.Et al.(2021), intramedullary fixation of trochanteric fractures can be safely performed by senior residents without immediate consultant supervision, journal of surgical education, vol.79, number 1, pages 260-265 (finland).The objective of this study is to assess the safety of senior residents performing trochanteric hip fracture surgery without immediate consultant supervision.Between 2011 and 2016, a total number of 966 patients (987 consecutive trochanteric fractures) underwent anatomical fracture reduction and appropriate osteosynthesis confirmed with intraoperative fluoroscopy.Open reduction (n=327) was performed if closed reduction was considered inappropriate.A proximal femoral nail anti-rotation device (pfna, depuy synthes, (b)(4), usa) was used as fixation device for all fractures.The following complications were reported as follows: mechanical complication: (n=13) blade cut-off.(n=7) migration.(n=11) superficial infection.(n=17) deep infection.(n=19) peri-implant fracture or implant failure.4 fractures (operated on by residents alone) needed revision surgery due to a technical error: a blade outside the intramedullary nail (n=1), a distal locking screw outside the nail (n=1), malreduction (n=1) and an unobserved intraoperative fracture at the tip of the nail (n=1).Other reasons for an early reoperation were haemorrhage (n=2) and an early infection (n=1).This report is for an unknown synthes pfna blade.This report captures the reported events of blade cut-off and a blade outside the intramedullary nail.This is report 3 of 5 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.510k: this report is for an unknown pfna blade/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.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 - 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: 14988738
• MDR Text Key: 295715959
• Report Number: 8030965-2022-04772
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 07/12/2022
• 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