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 No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Without a lot number the device history records review could not be completed.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.

Event Description

It was reported that two (2) intermaxillary fixation (imf) screws broke during surgery.The surgery was performed to repair a fractured mandible in male patient.The delay to the case was less than one minute as the surgeon implanted four additional imf screws, part number 201.932e.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device investigation summary ¿ the following device(s) were received: 2.0mm imf screw (part # 201.9xx | lot # unknown) quantity: 2.Both screws were returned with the tips broken off.The tips of both screws were not returned.The other parts of the screws are in good condition with no other observable damage.It is unknown what caused the complaint condition, but it is possible that the screws were being inserted into dense cortical bone without first pre-drilling.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Device drawings for the device(s) 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.Proper use and maintenance for the device(s) are 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.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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5267116
• MDR Text Key: 32677867
• Report Number: 2520274-2015-17677
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• 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: 11/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1