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

Model Number	201.932
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is a synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 or Problem Description
Device report from synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent an unknown procedure.During the procedure, the holding sleeve of the intermaxillary fixation (imf) screw did not hold the head of the screws well; when the screws were placed they move a lot, making placement difficult.It was noted a lot of force was placed on two (2) self-drilling intermaxillary fixation (imf) screws to place them.It is unknown if there was a surgical delay.Procedure outcome and patient status were unknown.This report is for an intermaxillary fixation (imf) screw.This is report 3 of 3 for (b)(4).

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 12MM
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8377933
• Report Number: 8030965-2019-61549
• Device Sequence Number: 429432
• Product Code: DZL
• UDI-Device Identifier: 20887587028658
• UDI-Public: (01)20887587028658
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K010527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 201.932
• Device Catalogue Number: 201.932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/28/2019
• Patient Sequence Number: 1