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

Catalog Number 201.928

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4); lot number unknown.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history record review could not be completed.The date of manufacture is unknown.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 during a surgery to treat a fractured mandible on (b)(6) 2017, the 8.0mm intermaxillary fixation (imf) screw head broke off upon insertion into the jaw.The screw head was retrieved but the shaft was retained in the patient.There was no surgical time delay and no additional medical or surgical intervention.The procedure was successfully completed.The patient status outcome is unknown.Concomitant devices reported: insert mandibular screw(s) - part# - unknown, lot# - unknown, quantity# - unknown, imf insert wire - part# - unknown, lot# - unknown, quantity# - 1; and a limited dynamic fixation plate - part# - unknown, lot# - unknown, quantity# - 1.This report is 1 of 1 for (b)(4).

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.

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW, FIXATION, INTRASSEOUS
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6433913
• MDR Text Key: 70864446
• Report Number: 2520274-2017-11064
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN IMF WIRE, QUANTITY 1; UNKNOWN MANDIBULAR SCREWS, QUANTITY UNKNOWN; UNKNOWN, LIMITED DYNAMIC FIXATION PLATE, QTY 1
• Patient Age: 37 YR