MAUDE Adverse Event Report: SYNTHES USA; BIT, DRILL

Device Problem Failure to Align (2522)

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

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

Additional patient information: patient height reported as (b)(6).This report is for one (1) unknown drill bit.(other): without a valid part and lot number, the udi is not available.Device is an instrument and is not implanted or explanted.The complainant part is not expected to be returned for manufacturer review/investigation.Reporter last name not provided.(b)(4).Pma#: unknown, as specific part and lot numbers for the complainant drill bit were not provided.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 sustained a complex femur fracture that required surgical fixation, which was undertaken on (b)(6) 2016.During nail insertion, the surgeon placed the reconstruction screw through the head of the femur.While drilling, an attempt to remove the guide wire from the protection sleeve was made; however, the drill missed the nail and crossed posterior.The nail was removed for additional fracture reduction.Upon completion, the nail was then re-inserted, but the drill missed again.Two (2) of the attempted reconstruction screws wound up being disposed of during this process (for unknown reasons).However, alternates were readily available for use.The surgeon ultimately made the decision to push on the aiming arm with the goal of "flexing" it in order to achieve correct positioning, which would allow for proper drilling of the nail.The procedure was completed with a delay of one (1) hour.Post-operatively, the patient was reported as being stable.It was noted that all instrumentation was checked prior to the start of the surgical procedure.No devices were found to be loose at that time.Concomitant device(s) reported: recon screws (part/lot: unknown / quantity: 2), femur nail (part/lot: unknown / quantity: 1), protective sleeve (part: 03.010.075 / lots: 34695 and 32353a / quantity: 2), guide wire (part: 03.010.076 / lot: 32740 / quantity: 2), and trocar (part: 03.010.077 / lot: unknown / quantity: 2).This report is for one (1) unknown drill bit.This report is 2 of 2 for (b)(4).

• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5879900
• MDR Text Key: 52234434
• Report Number: 2520274-2016-14127
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNKNOWN FEMUR NAIL
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 102