MAUDE Adverse Event Report: SYNTHES (USA) 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION, INTRAOSSEOUS

Catalog Number 201.928

Device Problem Break (1069)

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

Event Date 12/22/2014

Event Type  Injury  

Event Description

Synthes (b)(4) reports in an event in (b)(6) as follows: an intermaxillary fixation screw broke during surgery on (b)(6) 2014.Surgery was prolonged approximately 60 minutes due to the reported event and the positioning of a second screw.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device broke intraoperative and was not implanted or explanted.Subject device has been received; no conclusion could be drawn as the product is entering the complaint system.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.

Manufacturer Narrative

An investigation summary was performed.The investigation of the complaint articles has shown that: our investigation shows that the screw head is broken off at the threaded shaft.The broken off part is missing.The manufacturing review could not be performed as the lot number of the screw is unknown.Based on the provided information and without all involved parts, it is impossible to determine the cause of this occurrence and no final conclusion is possible.The fracture face of the screw is homogenous, which indicates material conformity and has the typical view of a forced fracture.Based on that we can only assume that a mechanical overload during the insertion caused this breakage.We are not able to determine the exact cause of this occurrence as no detailed clinical information is available and therefore no corrective action can be defined.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.

Manufacturer Narrative

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 that it was the lower left screw that fractured at the head of the screw.It was also reported that the body of the screw was not recovered.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• 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: 4431054
• MDR Text Key: 5278819
• Report Number: 2520274-2015-10480
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 67