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

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

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient¿s information is unknown.The 510k: this report is for an unknown proximal femoral nail antirotation-ii.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event may have required medical/surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.A male patient experienced nail protrusion.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.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 review of the following literature article: hu, s.J.Et.Al.(2016).Pfna-ii protrusion over the greater trochanter in the asian population used in proximal femoral fractures.Indian journal of orthopaedics, 50(6), 641.(b)(6).The study was conducted with the aim to determine whether the proximal segment length of the current proximal femoral nail antirotation-ii (pfna-ii) was suitable for the greater trochanter height.This study was conducted based on the retrospective assessments of postoperative radiograph measurements and clinical records of fifty-one (51) consecutive patients with per/intertrochanteric fractures that were treated with pfna-ii between july 2012 and december 2012.These fifty-one (51) patients were selected based on the inclusion criteria of being >= sixty (60) years of age, fracture being treated with closed reduction and pfna-ii fixation, and lastly getting standard pelvic ap radiographs taken within two (2) weeks postoperatively.The pfna-ii nails implanted were systematically selected such that they were as thick and long as possible, provided that the nail could be manually inserted into the femoral canal without additional distal segment reaming.The most commonly used nail was the short-sized nail, measuring 200 mm in length and 10 mm in diameter.The study population included of nineteen (19) male and thirty-two (32) female patients; average age being 78.6 years (rage 66-92 years).Twenty-seven (27) cases involved the left hip and twenty-four (24) cases involved the right hip.The causes of injuries were described as low energy violence, which included falling while standing in forty-three (43) cases and pedestrian accidents in eight (8) cases.After being implanted with the pfna-ii, the patients were checked for having lateral trochanter pain after their fracture was healed during the follow-ups at four (4) weeks, eight (8) weeks, three (3) months, six (6) months and one (1) year after operation.Five (5) patients died within one (1) year of the initial pfna-ii implant surgery and four (4) patients were unable to walk or stand independently or with an orthopedic walker.The remaining forty-two (42) patients were followed-up at an average of 15 +- 2.6 months, and these patients were reported to be able to walk independently or with a stick.The following complications were identified with the use of pfna-ii postoperatively: nail protrusion was observed in forty-five (45) out of fifty-one (51) patients; fifteen (15) being males and twenty-nine (29) being females.Thirty-one (31) out of fifty-one (51) patients had protrusions greater than five (5) mm; eight (8) being males and twenty-three (23) being females.Thirteen (13) patients had lateral trochanter pain on the injured side.Protrusion was reported to be approximately 11.13 mm in these patients with lateral trochanter pain as compared to the other twenty-nine (29) without pain having about 3.87 mm of protrusion.Four (4) patients were unable to walk or stand independently or with an orthopedic walker.Five (5) patients were reported to have died within one (1) year of the initial implant surgery.This report is for an unknown proximal femoral nail antirotation-ii.This report is for a male patient who experienced nail protrusion postoperatively.Concomitant devices reported: unknown helical blade (part# unknown, lot# unknown, quantity# unknown).This complaint involves total 46 reportable impacted products.Complaint (b)(4) captures 9 impacted products, the remaining 37 impacted products have been reported under following four linked complaints: (b)(4).This is report 2 of 9 for complaint (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: 7408797
• MDR Text Key: 104805219
• Report Number: 8030965-2018-52903
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention