MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ROD,FIXATION,INTRAMEDULLARY

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

Patient Problems Death (1802); Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided for reporting.Date of event is unknown.This report is for one (1) unknown pfna nails.Part#, lot# and udi # is not available.Reporter contact information was not provided for reporting.This report is for one (1) unknown pfna nails.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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.(b)(4).

Event Description

This report is being filed after the subsequent review of the following literature article lang, n., joestl, j., payr, s., platzer, p.And sarahrudi, k.(2017) secondary femur shaft fracture following treatment with cephalomedullary nail: a retrospective single-center experience.Arch orthop trauma surg, volume 137: 1271-1278.(b)(6) the purpose of this article is to assess the impact of revision surgery and general state of health on mortality and functional outcomes in patients suffering femur fractures following treatment with cephalomedullary nails.This retrospective study occurred between january of 2000 to december of 2015.The study included 42 patients with 43 secondary femur shaft fractures with a mean follow- up time of 26 ± 9.7 months after secondary femur fracture.There were 5 male and 37 female patients, yielding an average age of 83.6 ± 9.7 years at the time of secondary injury.Of the forty-two (42) patients, eight (8) patients received the pfna nail (synthes), seventeen (17) patients received the gamma2 nail, twelve (12) patient received the gamma3 nail and six (6) patient received the long cmn nail.Complication ¿ seventeen (17) unknown patients sustained a secondary femur fracture within 10 weeks (6.1 ± 2.4 weeks) and three (3) unknown patients sustained a secondary femur fracture within 6 months of initial surgery.All patients suffered from a simple fall¿no high-impact injuries were recorded.Two (2) unknown patients with ipsilateral total knee replacements suffered from vancouver d interprosthetic fractures.In all of these patients, the standard cephalomedullary nail was removed and replaced by a long nail.Three (3) unknown patients developed pneumonia (confirmed via chest radiograph), which was treated with intravenous antibiotics.Two (2) unknown patients suffered from decubitus ulcers in the course of delayed mobilization.Eight (8) unknown patients sustained mild urinary tract infections, which were treated with oral antibiotics.Three (3) unknown patients with cephalomedullary nails were loose due to fracture and non-union of the trochanteric fracture.One (1) unknown patient suffered from lateralization of the lag screw.Three (3) unknown patients died within 30 days after surgery and an additional three (3) unknown patients died within 90 days (27 ± 24 days) after surgery.Cardiopulmonary failure following surgery for secondary femur fracture was the cause of death in all of these patients.Four (4) of these patients died during their hospital stay, while two (2) of those patients died subsequent to discharge from hospital, in a special nursing facility.One (1) unknown patient died within 8.5 months after surgery for secondary femur fracture from deep wound infection leading to septic non-union.She underwent removal of her implants and subsequent treatment with external fixator.After a prolonged icu stay, she succumbed to multiorgan failure.Two (2) unknown patients died within 1 year after surgery, due to generally poor health.One (1) unknown patient developed a non-union; she was, however, in generally poor health, to the extent that no further surgical treatment was possible.She later died 1 year after surgery.This report is for one (1) unknown pfna nail for : one (1) unknown patient died within 8.5 months after surgery for secondary femur fracture from deep wound infection leading to septic non-union.She underwent removal of her implants and subsequent treatment with external fixator.After a prolonged icu stay, she succumbed to multiorgan failure.This is report 5 of 5 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7365742
• MDR Text Key: 103323621
• Report Number: 8030965-2018-52348
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention