MAUDE Adverse Event Report: SYNTHES MONUMENT; SCREW FIXATION INTRAOSSEOUS

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 08/12/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for (1) unknown 12mm transmaxillary screw /unknown lot number.Device malfunctioned intra-operatively and was not implanted / explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Pma/510k#: unknown.(b)(4).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided.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 on an event in (b)(6) as follows: it was reported that during fast locking the 12mm transmaxillary screw broke into 2 parts.The screw broke in the bone and was blocked.A milling around the screw was necessary to extract the screw.A new screw was used to finish the procedure.No surgical delay is reported.No information available about patient condition and outcome.This complaint involves 1 part.Concomitant reported part: 1x unknown screwdriver.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

2.0mm imf screw self-drilling 8mm or 2.0mm imf screw self-drilling 12mm.During the investigation, it was determined that the part# is either 201.928 or 201.932.Udi# (b)(4).Product development investigation was completed.The received screw was found broken at threaded shaft.The broken part is missing.Furthermore, there are white residues visible at the thread.The screw was identified as a imf screw but without broken part it is not possible to address the device to the correct article number (201.928 or 201.932).The manufacturing review could not be performed as no lot number was made available.Due to the limited information provided, how this happened could not be confirmed.Because of the damage and without broken part the complaint relevant dimensions cannot be checked for dimensional accuracy.It can be assumed that most probable cause of the breakage is due to mechanical overload situation during the use.This complaint is confirmed due to the breakage but is classified as indeterminate from an investigation standpoint.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 further reported that on (b)(6) 2017, patient fell onto the chin and had non-displaced symphyseal mandibular fracture.

• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6914745
• MDR Text Key: 88204107
• Report Number: 2520274-2017-12397
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 10/26/2017; 12/06/2017
• Supplement Dates FDA Received: 11/17/2017; 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1X UNKNOWN SCREWDRIVER.
• Patient Outcome(s): Required Intervention