MAUDE Adverse Event Report: SYNTHES USA 2.0MM THREADED GUIDE WIRE 230MM; WIRE, SURGICAL

Catalog Number 292.65

Device Problem Sticking (1597)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 12/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional product codes for this report include jdw.(b)(4).Device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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 a patient underwent a right hip rotational osteotomy procedure on (b)(6) 2015.During the procedure, the guide wires were inserted according to the technique guide and a cut was made for the osteotomy.At that point, a 2.7mm pediatric locking compression plate (lcp) and two (2) 2.7mm locking screws were inserted.As the surgeon attempted to remove the second guide wire, it became bound to the plate and would not come out.The surgeon decided to remove the plate and screws and implant a new construct.During insertion of the new locking screws, one (1) became damaged due to positional change and was removed.A total of four (4) locking screws were ultimately implanted with the aid of additional x-rays for proper placement.A thirty (30) minute surgical delay was noted.The procedure was completed.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.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

This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Product investigation summary: the following complaint devices were received: one pediatric lcp hip plate 2.7mm/100°/2 holes.One unknown guide wire.One unknown screw - please note: the unknown screw had no allegation against it.Upon investigation, it was determined that the unknown guide wire is most likely part number 292.65, based on the length, color, and diameter of the returned instrument.Visual inspection showed the guide wire is stuck onto the plate and cannot be separated.A root cause could not be determined, but most likely the wear marks on the guide are indicating that a drill was used to insert the guide wire.The guide wire was being removed under power and too much torque was generated causing the guide wire to go off axis and become stuck onto the plate.This complaint is confirmed.Both of the complainant devices are part of the pediatric lcp plate system.The system is utilized for osteotomies and fracture fixation of the proximal and distal femur in infants, children, adolescents, and small statured adults.The relevant drawings for both of the returned parts were reviewed.The designs, materials, and finishing processes were found to be appropriate for the intended use of these devices.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 2.0MM THREADED GUIDE WIRE 230MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5326502
• MDR Text Key: 34324168
• Report Number: 2520274-2015-18096
• Device Sequence Number: 1
• Product Code: LRN
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• 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: 8 YR