MAUDE Adverse Event Report: SYNTHES USA ROD, FIXATION, INTRAMEDULLARY

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 05/31/2016

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis. This report is for an unknown pfna ii system (unknown quantity/unknown lot). The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided. (b)(4). 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 subsequent review of the following literature article: cho, w; et al (2016) provisional pin fixation can maintain reduction in a3 intertrochanteric fractures. Arch orthop trauma surg, 136:945-955. This retrospective study introduces a modified provisional guide pin fixation technique and analyze the factors affecting intraoperative reduction loss, especially in comparison between two methods. Between july 2013 and june 2015, 11 patients received provisional guide pin fixation-assisted cephalomedullary nailing (pfna ii, depuy synthes, usa) for ao/ota 31 a3 intertrochanteric fractures. Mean patient age was 73 years (range 58¿82 years). The aim of provisional pin fixation is temporary maintenance of reduction stability between main fragments using a single threaded guide pin without the interferences of nailing procedures. Following provisional pin fixation, instruments used for the percutaneous reduction were released and could be removed from the fracture site such that the provisional pin alone was enough to maintain reduction during intramedullary nail insertion. One case of reduction loss was observed when the nail was inserted after provisional pin fixation. In this case, reduction was restored with addition of supplementary percutaneous reduction instruments. All patients were permitted to follow routine rehabilitation protocols in our hospital including standing exercises 2 days after surgery, and walking training with a crutch or walker 3 days after surgery. This report is 1 of 1 for (b)(4). This report is for an unknown pfna ii system and refers to the serious injury of case 1, (b)(6) male patient who experienced a loss of reduction.

Manufacturer Narrative

Device code was added for no known product problem. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6271017
• MDR Text Key: 65526134
• Report Number: 2520274-2017-10250
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/23/2017 Patient Sequence Number: 1