MAUDE Adverse Event Report: SYNTHES USA 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM; BONE PLATE

Catalog Number 04.511.206.01C

Device Problems Failure To Adhere Or Bond (1031); Failure to Align (2522); Device Operates Differently Than Expected (2913)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: an inferior plate hole was slightly contoured to lower border of mandible, which resulted in the screw passing straight through the plate and screw head did not engaging with plate.The surgery was prolonged about 15 minutes.The plate was completely removed and a standard 4-hole plate was used instead.This report is for an unknown screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.Report is for one (1) unknown screw.Reported device not implanted / explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Brand name and part number were identified during the manufacturing investigation of the received subject device.The lot number was not provided by the reporter and could not be identified during the investigation.A manufacturing investigation was performed for the subject device (part number 04.511.206.01c, 1.85mm ti matrix screw self-tapping/6mm, lot number unknown).The subject device was received was received with the outer diameter of the screw head flattened, the cruciform recess badly damaged and visible stress marks between the thread flanks.The relevant dimensions of the screw head cannot be verified anymore due to the damages.At all damage locations the anodized layer is worn out, which is clear indication that the damages were caused post-manufacturing by an excessive contact with the plate.The stress marks at the screw shaft are an indication that the screw was already at the beginning of the insertion in the contact with the plate, which could indicate an excessive insertion angle.In additional, the damaged cruciform is an indication that high force was applied onto this screw during the insertion, which also indicates excessive contact force with the plate.The complaint is confirmed as the screw passes through one hole of the plate as complained, but not manufacturing related as the damages at the screw were clearly caused post-manufacturing.Common name and device product code were corrected in accordance with the identification of the part number.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4827421
• MDR Text Key: 18000663
• Report Number: 2520274-2015-14334
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.206.01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27 YR