MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 06/06/2013

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during a planned removal surgery on (b)(6) 2013, the screws were difficult to remove.The patient had undergone an internal fixation with lag screws and angular stable plate of the left lateral tibial head fracture on (b)(6) 2011.It was reported that post-operatively the patient had continued to experience localized symptoms in the area of the bend of the angular stable l-plate.The patient had wanted to get the implants removed; however, an x-ray revealed a residual gap indicating healing was not complete.Almost two years after the internal fixation, a ct scan of the left tibial head has been recorded to document the bone healing.The scan shows complete bone consolidation in the anterior sections of the tibial head and a roughly pea-sized subchondral cyst in the area of the former fracture gap.Signs of bone consolidation are also apparent in the posterior sections of the former fracture.The four proximal screws were stuck so tightly that none of the four screws could be removed with the normal allen key.All four heads just spun round.The special instrument set was then opened, and at least one of the four screws could be grabbed and then unscrewed using the special instruments for spinning screw heads.The threads on the other three screws could not be anchored sufficiently with the special instruments, and even after the screw heads were drilled with the diamond drill none of them could be removed with the special instruments.The three distal angular stable screws could be removed without problems using the allen key.By contrast, a more proximally located angular stable screw initially spun round and could not be removed even with the special instruments.Therefore, the heads of a total of four angular stable screws had to be drilled out completely from the plate using the 3.5 drill, and the l-plate loosened with the chisel and removed.Drilling was then continued over the four remaining threaded cores until these could be removed using the special instruments.A titanium cannulated cancellous bone screw with washer inserted from outside the l-plate was then located under image intensifier control.The screw head was exposed and the screw, together with washer, unscrewed and removed without difficulty.The resulting holes in the tibia and the surrounding soft tissues were then irrigated liberally, paying particular attention to the removal of as much as possible of the metal swarf formed during the drilling operations.The muscle fascia in the distal section and the proximal part of the iliotibial tract was then closed using strong absorbable sutures.The subcutaneous cavity was drained with a thin redon drain led out through a separate incision.The skin was closed with vertical mattress sutures according to (b)(6).A sterile dressing was applied.This report is for an unknown drill bit.This is report 10 of 10 for (b)(4).

Manufacturer Narrative

This report is for an unknown drill bit /unknown lot.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Product investigation summary: it was a planned implant removal.The patient wished to have the implants removed after two years in-situ.According to the received documents, the patient was informed prior to the surgery (by the surgeon) about the possible difficulties in relation to spinning/ cold-welding of the screw heads and possible breakage of the osteosynthesis materials.The present complaint was sent in by the patient himself as he wanted to get some technical feedback.A review of the device history records found no issues that would have contributed to this complaint condition.No manufacturing related failure could be detected.A visual inspection confirmed several broken screw heads with drilled out screw recess.A dimensional inspection could not be performed due to the damage incurred.No indication for material or design related issue.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 procedure was scheduled to take 1.5 hours, but wound up taking almost 4 hours to complete.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4413201
• MDR Text Key: 18067128
• Report Number: 2520274-2015-10313
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR