MAUDE Adverse Event Report: SYNTHES (USA) 4.5MM CORTEX SCREW SELF-TAPPING 38MM; SCREW,FIXATION,BONE

Catalog Number 214.838S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

Patient weight is not available for reporting.Additional code: ktt.(b)(4).Device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.(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.(b)(4).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 patient was implanted with a competitor¿s titanium cephalomedullary nail on unknown date.Patient was returned to surgery on (b)(6) 2017 where surgeon attempted to correct patient¿s deformity with the proximal femoral plaque system.Surgeon was not able to explant the nail and instead opted to implant the stainless steel 4.5 mm cortex screw to block distally the cephalomedullary nail.Surgeon noted the difference in materials but still opted to implant the stainless steel cortex screw.Surgeon stated the hardware will be explanted when the patient¿s injury is consolidated.Surgery was completed successfully with no delay.Patient outcome was not available.Concomitant devices reported: competitor¿s cephalomedullary nail (quantity 1).This report is for one (1) 4.5 mm cortex screw.This is report 1 of 1 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 38MM
• Type of Device: SCREW,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: 6454888
• MDR Text Key: 71547820
• Report Number: 2520274-2017-11166
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K112583
• 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: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214.838S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• 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: CEPHALOMEDULLARY NAIL (PART AND LOT UNKNOWN, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR