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

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown. This report is for one (1) unknown pfna blade. Pma/510(k) number is not available. Part#, lot# and udi # is not available. Implanted, explanted dates: unknown. Device is not expected to be returned for manufacturer review/investigation. This report is for one (1) unknown ffna blade. Pma/510(k) number is not available. 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. 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) carulli, c. Literature article. Pdf].

Event Description

This report is being filed after the subsequent review of the following literature article, carulli, christian and et al. (2017) "a comparison of two fixation methods for femoral trochanteric fractures: a new generation intramedullary system vs sliding hip screw". Clinical cases in mineral and bone metabolism, 2017; 14 (1):40-47. (italy). A prospective study was performed on (140) consecutive patients affected by a trochanteric fracture treated by internal fixation with either proximal femoral nail antirotation (pfna) or dynamic hip screw (dhs) between january 2007 to december 2009. Two groups were created; group a that had pfna treatment and was composed of 71 patients (29 male, 42 female with mean age of 81. 6 years) and group b that had dhs treatment and was composed of 69 patients (25 male, 44 female, with mean age of 83. 4 years) all subjects were evaluated with clinical and radiologic follow up. Two (2) patient were lost to follow up after the 3 month evaluation and four (4) patients did not attend the last follow up visit in total from the study. Group a pfna complications: death. Two (2) patients died; (one (1) patient died related from pulmonary embolism 9 days after surgery, the other died of unknown causes) serious injury. One (1) case of pulmonary infection. Two (2) cases of deep vein thrombosis (dvt). Five (5) cases of non-union at 6 months post-operatively with reports of pain and limited range of motion. Seven (7) cases of periarticular ossification discovered during postoperative follow up. Serious injury and device malfunction: one (1) case of implant failure (nail cut out) one month after surgery in an (b)(6) year old patient (reported pain and required revision surgery). Two (2) cases of spiral blade medial migration through the femoral head. One (1) case of lateral protrusion of the blade with trochanteric bursitis. This complaint captures the events from the pfna (group a); (b)(4) captures the events from the dynamic hip screw (dhs) system (group b). This report is for one (1) unknown proximal femoral nail antirotation (pfna) blade. This is report 3 of 4 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: 7335294
• MDR Text Key: 102315995
• Report Number: 8030965-2018-52005
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/13/2018 Patient Sequence Number: 1