MAUDE Adverse Event Report: SYNTHES USA 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM; MANDIBLE DISTRACTION DEVICES

Catalog Number 400.810.96

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

Patient Problems Sedation (2368); Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.(b)(4).The device broke intra-operatively and was not fully implanted or explanted.Per facility, the complainant parts have been discarded and are no longer available for evaluation.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 surgical procedure on (b)(6) 2016 to repair two (2) bones in the right hand.During final tightening, the heads of two (2) screws spun off leaving the shafts in the third or fourth metacarpal bones.The heads were retrieved and discarded.Efforts were then made to extract the shaft fragments from the bone with the use of hemostat and a screw removal tray.Ultimately, the surgeon decided to leave the fragments in situ in order to avoid creating a big hole in the patient¿s finger.Per the surgeon, no additional cuts were made during the screw removal attempt.The issue resulted in a forty (40) minute surgical delay, but it is unclear as to whether or not additional anesthesia was administered during this time.The patient¿s post-operative status was reported as stable.This report is 2 of 2 for (b)(4).

• Brand Name: 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM
• Type of Device: MANDIBLE DISTRACTION DEVICES
• 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: 5662510
• MDR Text Key: 45399892
• Report Number: 2520274-2016-12721
• Device Sequence Number: 1
• Product Code: MQN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK981275
• 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
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.810.96
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• 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: 24 YR