MAUDE Adverse Event Report: SYNTHES, USA 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.003.028

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).As of the date of this report, device stayed implanted in the patient.(b)(4).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

On (b)(6) 2016, patient underwent an intramedullary nailing procedure.It was reported that during the procedure, a reamer head would not go on the flexible reamer shaft.The surgeon did have another reamer shaft on hand for use.In the same procedure a screw would not advance while putting it through the nail.The screw was reported as not going in or coming out.It caused a 30 minute delay in surgery to pull the screw out.Another screw was obtained, which also got stuck.This time a mallet was used to hammer the screw in the nail to get it past the threading.This caused the surgeon to put a larger incision in the patient.The surgery was completed successfully and patient was reported as being stable.Concomitant devices reported: reamer head (part# unknown, lot# unknown, quantity 1).This is report 3 of 3 for (b)(4).

Manufacturer Narrative

(b)(6).Device implanted in the patient, not expected to return to manufacturer for investigation.Device 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.

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 90MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES, USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5923158
• MDR Text Key: 53780676
• Report Number: 2520274-2016-14418
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 04.003.028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• 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: UNKNOWN REAMER HEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 82