MAUDE Adverse Event Report: SYNTHES (USA); PIN,FIXATION,SMOOTH

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information not available for reporting.This report is for an unknown locking bolt.Part and lot numbers are unknown; udi number is unknown.Device remains implanted and was not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it is reported during a procedure to implant a (b)(4) proximal femoral nail antirotation on (b)(6) 2017; surgeon also implanted a 42mm locking bolt.Measurements taken for the necessary bolt length showed 42 mm.Patient physiques is reported as ¿somewhat big¿, surgeon expressed a desire to use a 44mm bolt, which was not available.Surgeon expressed concern for the strength of fixation due to the smaller bolt being used.Surgery was delayed approximately 2 minutes due to this issue.Concomitant devices reported: pfna (part number unknown, lot number unknown, quantity 1).This report is for one (1) locking bolt.This is report 1 of 1 for (b)(4).

• Type of Device: PIN,FIXATION,SMOOTH
• 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: 6517034
• MDR Text Key: 73626109
• Report Number: 2520274-2017-11482
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• 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
• Treatment: PFNA NAIL (PART AND LOT UNKNOWN, QTY 1)