MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problems Dull, Blunt (2407); Failure to Advance (2524); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/08/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report is for one (1) unknown 4.0mm cannulated screw.Due to the intra-operative events, the screw was not successfully implanted.An alternate device was used to complete procedural step.As such, no implant/explant dates are applicable.It is unknown if the complainant part will be returned for evaluation.(b)(4) the intra-operative images that were taken due to the advancement issues encountered with the screw.(b)(4) the unknown debris that became visible during insertion/advancement.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 scheduled bunion repair procedure to correct a hallux valgus cheilectomy.During the procedure, the surgeon encountered an issue with a 4.0mm cannulated screw.As the surgeon was attempting to advance the screw into position, unknown debris became visible as the screw was placed over the guide wire.The surgeon over-drilled the proximal aspect for screw advancement with no issues.However, as the screw was advanced into the distal part of the fusion, it became increasingly difficult to move and began to strip.At that time, x-ray images were taken to confirm that the location of the screw was not in the cortex.Based upon the images, the surgeon felt he was in an appropriate position.Due to the advancement issues, however, the screw was removed with the use of a rongeur.An alternate 4.0mm cannulated screw was available and successfully advanced across the fusion site with no reported issues.The procedure was completed with a two (2) minute prolongation, but the end result was said to be satisfactory.Upon inspection of the original screw, the device was noted to have twisted upon itself.This report is for one (1) unknown 4.0mm cannulated screw.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The subject device has been received and is currently in the evaluation process.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.A product development investigation was performed for the subject device (4.0mm cannulated screw, unknown part number 207.6xx or 207.7xx, lot number unknown).The subject device was received broken through the treads and the tip of the screw was not returned.Approximately 30mm of the implant was returned.Since the balance of the device was not returned, the exact part number is unable to be determined.Drawings for possible part numbers 207.610 and 207.716 were reviewed.No drawing issues or discrepancies were noted.The design was determined to be suitable for the intended use when employed and maintained as recommended.A review of the device history records was unable to be performed since the lot number was unknown for the device.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Although the complaint condition was confirmed, a root cause could not be determined.It is possible that the screw was inserted into excessively hard bone which caused the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SCREW, FIXATION, BONE
• 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: 5615921
• MDR Text Key: 43923003
• Report Number: 2520274-2016-12337
• Device Sequence Number: 1
• Product Code: HWC
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR