MAUDE Adverse Event Report: SYNTHES MEZZOVICO 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.928

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided for reporting.(b)(4) lot# unknown.Event occurred intraoperative.Device was not implanted/explanted.(b)(6).The device was received and the product evaluation is in progress.No conclusion can be drawn.Device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported on an unknown date, during the surgery two screws broke while surgeon tried screwing unit into patients mouth.Damaged screws were removed and new ones were used.Reportedly, there was thirty (30) minutes delay to the procedure.No reported adverse event to patient reported.Concomitant parts reported: screwdriver (quantity 1).This report is for one (1) 2.0 mm imf screw self-drilling 8 mm.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was performed.One (1) imf screw (201.928s/unknown lot) was received for investigation.The visual investigation has shown that the imf screw we received back is broken in two parts, this thus confirming the complaint description.The threads (distal part) that remain are in relatively good condition, and the screw head is in good condition.The tip (proximal part) is in used but good condition, but the opposite side is badly damaged/worn.Since only the fragments of the screw were returned and no lot number was provided the complaint cannot be fully analyzed neither a review of the device history records could be performed nor could a review of the drawing be performed as we are not able verify the right index.We assume that the damage at the tip part on the proximal end resulted from removal with pliers.The relevant dimension of the screw cannot be measured due to its broken off/damaged condition and the unknown drawing.Unfortunately we are not able to determine the exact reason for this occurrence.A product failure could not be detected.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 INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6833906
• MDR Text Key: 84136957
• Report Number: 1000562954-2017-10214
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

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: Physician
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) UNKNOWN SCRWEDRIVER