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

Catalog Number 201.928

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during a midface and mandible fracture case, eight (8) intermaxillary fixation (imf) screws were inserted and one (1) imf screw broke.The screw was inserted with an unknown imf self-retaining screwdriver.As the screw was inserted almost completely, the head of the screw broke from the shaft of the screw.The shaft of the screw remained in the patient and there was a minimal part of the screw protruding out from the bone, not allowing it be removed.The surgeon said that it is better for the damaged shaft of the screw to remain in the patient temporarily.A new imf screw was used adjacent to the damaged screw.There was no adverse consequence.There was a one (1) minute delay to the procedure reported.Concomitant device reported: screwdriver (part# unknown, lot# unknown, quantity #1).This report is for one (1) 2.0mm imf screw self-drilling.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Complainant part is not expected to be returned for manufacturer review/investigation.Additional information provided.Complaint is confirmed as we are able to confirm complaint description based on the received pictures.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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8021460
• MDR Text Key: 125610654
• Report Number: 8030965-2018-57759
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819724358
• UDI-Public: (01)07611819724358
• Combination Product (y/n): N
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 11/26/2018
• Patient Sequence Number: 1
• Patient Age: 17 YR