MAUDE Adverse Event Report: SYNTHES (USA) 2.8MM GUIDE WIRE WITH FLUTES 450MM; PIN, FIXATION, SMOOTH

Catalog Number 02.207.001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/11/2014

Event Type  Injury  

Event Description

It was reported that while performing a slipped capital femoral epiphysis screw (scfe) using the synthes scfe system.The surgeon inserted 2.8 guide pin in normal fashion, and accepted the position using x-ray.The physician inserted the 10mm 5.0/7.3mm, the stepped reamer was inserted over the guide pin, and the physician began reaming.While reaming, the guide pin bound up and was forced out of the femoral head, into acetabulum.The surgeon then retracted the reamer for fear of inserting wire into the pelvis and damaging the bladder.As the reamer was retracted, the guide pin came out and was reported to be lodged inside the reamer.A new guide wire was inserted the bone re-reamed, and screw inserted.The surgery was then completed successfully and no visible fragments of guide pin were left in the patient.The event resulted in a reported delay of 15 minutes.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: an evaluation was performed on the returned device.As received condition of device; the 2.8mm guide wire was received intact.The guide wire is gouged impacting a 41-60mm section of the guidewire inboard from the distal tip.The 03.207.001 & 02.207.001 are part of the slipped capital femoral epiphysis (scfe) screw system and is indicated for fracture fixation of large bones and large bone fragments, slipped capital femoral epiphyses, pediatric femoral neck fractures, inter-condylar femur fractures and sacroiliac joint disruptions.The returned stepped drill was received with the 5mm stepped cutting tips broken off and missing.The step drill was manufactured to specifications of drawing which has been determined suitable for the intended design, application and dimensional conformity for the stepped drill as well.The drill is cannulated and intended to be applied over the guide wire when drilling for the scfe screw placement.The chipped surfaces of the of the 5mm drill tip are homogenous indicating good material consistency and indicative of impact with the returned gouged guide wire.The gouged 41-60mm section of the guide wire was clearly impacted by the drill contacting the wire off angle.It is critical to a successful procedure to utilize the recommended guide wire and drill guide sleeves for proper location and alignment of the stepped drill and guide wire during application.The obvious off center method of use of the stepped drill and guide wire has led to this complaint.The employed method of use method use and or instrument condition has led to this confirmed complaint and is not the result of a design deficiency.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.8MM GUIDE WIRE WITH FLUTES 450MM
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 3844718
• MDR Text Key: 4405953
• Report Number: 2520274-2014-11659
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.207.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 06/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/10/2014; 09/11/2014
• 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: 13 YR
• Patient Weight: 71