MAUDE Adverse Event Report: SYNTHES (USA); NAIL,FIXATION,BONE

Device Problem Separation Failure (2547)

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

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.This report is for an unknown tibia nail.Part and lot numbers are unknown; udi number is unknown.Device 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 the (b)(6) as follows: it was reported during an unknown procedure on an unknown date, while using the suprapatellar nailing kit, surgeon was unable to disconnect the cannulated connecting screw for percutaneous instruments for nails-ex from the nail.It was confirmed the aiming arm had been removed prior to attempting to unscrew the connecting screw.Surgeon was eventually able to detach the connecting screw from the nail with considerable effort.It was also noted that the handle for protection sleeve is damaged; the black turnable knob is bent on its axis.Surgery was completed successfully with a delay of approximately 10 to 15 minutes.Patient outcome reported as normal.Concomitant devices reported: insertion handle for suprapatellar (part 03.010.440, lot 12-5882, quantity 1) this report is for one (1) unknown tibia nail.This is report 2 of 2 for (b)(4).

• Type of Device: NAIL,FIXATION,BONE
• 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: 6998343
• MDR Text Key: 91959022
• Report Number: 2520274-2017-12580
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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?: Yes
• Date Manufacturer Received: 10/10/2017
• 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