MAUDE Adverse Event Report: SYNTHES, USA 5.0MM TI LOCKING SCREW SELF-DRILLING 26MM; PLATE,FIXATION,BONE

Catalog Number 422.392

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant device: titanium distal femur liss plate 9 holes/236mm-left (part # 422.345, lot # unknown, quantity-1), locking screws (part # unknown, lot # unknown, quantity 6).Therapy date: unknown.(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 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

It was reported that the patient was originally implanted with one (1) titanium ti distal femur liss plate and eight (8) screws on an unknown date to treat a distal femur fracture.On (b)(6) 2016, the patient returned to the operating room to undergo the scheduled hardware removal surgery.During the surgery, while removing two (2) of the titanium locking screws with large hexagonal screwdriver shaft, the tip of the screwdriver shaft broke off in the screw head.Surgeon then used second large hexagonal screwdriver shaft to remove the screw and the tip of a second large hexagonal screwdriver shaft also broke off in the screw head.Both the broken tips of the screwdriver shafts were retrieved and no piece of the instruments remained in the patient.As per surgeon, these two (2) titanium locking screws were too tight and cold-welded into the plate.Therefore, surgeon first drilled out the heads of the screws to get the plate off and then removed the screw shafts with screw removal set.The tissue was cleaned and all fragments were completely removed from the patient.All the hardware was removed with no further complications.There was surgical delay of 10 minutes due to the reported event.Third screwdriver shaft was readily available to complete the procedure.Surgery was successfully completed with no patient harm.Patient status reported as stable.Concomitant devices reported as: titanium distal femur liss plate 9 holes/236mm-left (part # 422.345, lot # unknown, quantity-1), locking screws (part # unknown, lot # unknown, quantity 6).This is report 3 of 4 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

(b)(4).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: 5.0MM TI LOCKING SCREW SELF-DRILLING 26MM
• Type of Device: PLATE,FIXATION,BONE
• 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: 5924852
• MDR Text Key: 53823541
• Report Number: 2520274-2016-14421
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 422.392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR