MAUDE Adverse Event Report: SYNTHES USA 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.932E

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.(b)(4) lot unknown.Device broke during insertion; device not considered implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.Device was 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 during an open reduction internal fixation of a mandible fracture the imf self-drilling screw broke upon insertion.The tip of the broken screw remains in the patient and the surgeon inserted another screw beside the broken one.This caused a delay of less than thirty seconds as the surgeon had the other screw readily available.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: this complaint is confirmed, as the returned inter maxillary fixation (imf) screw was received with a portion of the threaded tip sheared off.The overall length of the returned imf screw measures approximately 9mm; the overall screw length specification for this imf screw (part 201.932e) per the product drawing is 18.25mm.The sheared off threaded tip fragment (approximately 9.25mm in length) was not returned for evaluation as per the complaint details, it remains in the patient.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.The relevant drawing for the device was 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.Proper use and maintenance for the device is addressed in the technique guide for the imf screw set.It is recommended that the surgeon pre-drill the hole for the imf screws when inserting into dense cortical bone.Unable to determine a definitive root cause.However, the complaint condition was most likely caused by not pre drilling in dense cortical bone.It is not likely that the design of the device contributed to this complaint.Device was 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 IMF SCREW SELF-DRILLING 12MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5630061
• MDR Text Key: 44344459
• Report Number: 2520274-2016-12502
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010527
• 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
• Report Date: 04/13/2016

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: 201.932E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• 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