MAUDE Adverse Event Report: SYNTHES MONUMENT 2.0MM IMF SCREW SELF-DRILLING 12MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 201.932

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4), lot unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Concomitant device reported: ratcheting screwdriver handle, part #-311.023, lot #-unknown.Matrixmandible/thorax screwdriver blade self retaining-long, part #-03.503.072, lot #-unknown.The surgeon had to burr down the shaft of the screw so it can sit flush with the bone.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.Report was initially submitted on nov 1, 2017, but the fda site was down.Advised by fda on nov 6, 2017 to resubmit medwatch.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 an intermaxillary fixation (imf) screw broke midway up the shaft while inserting the screw during an open reduction internal fixation (orif) mandible fracture on (b)(6) 2017.The surgeon tried to back the screw out but it would not come out.The surgeon used plate cutters to cut the screw shaft to the level of the bone and then burred it smooth.There was a 5 to 10 minute surgical delay.The screw shaft remained in the patient¿s mandible.The surgery was successfully completed with patient outcome as expected.This complaint has 1 device.Concomitant device reported: ratcheting screwdriver handle, part #-311.023, lot #-unknown.Matrixmandible/thorax screwdriver blade self retaining-long, part #-03.503.072, lot #-unknown.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product development investigation was completed.The investigation summary indicates that: an intermaxillary fixation (imf) screw broke midway up the shaft while inserting the screw during an open reduction internal fixation (orif) mandible fracture on (b)(6) 2017.The surgeon tried to back the screw out but it would not come out.The surgeon used plate cutters to cut the screw shaft to the level of the bone and then burred it smooth.There was a 5 to 10 minute surgical delay.The screw shaft remained in the patient¿s mandible.The surgery was successfully completed with patient outcome as expected.This complaint has (1) device.The lot number for the returned screws are unknown therefore a dhr review could not be completed.The returned screws were confirmed to be broken.The tip of the screws was sheared off and were not returned.Approximately 11-11.5 mm fragment is missing from the tip of the screw.Minor wear is noted to the screw head recesses.Deformation to the thread was noted adjacent to the breakage site on one of the screws.A material test was performed on the returned screw head.The screw tested as a match for ss 316.The element percentage ranges were determined to be within the specifications outlined in which is the specification document for 316l stainless steel specified in the product drawing.The complaint was confirmed.Replication of the complaint condition is not applicable.No additional malfunctions were observed during investigation.Device 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 12MM
• 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: 7004954
• MDR Text Key: 91186107
• Report Number: 1719045-2017-11146
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR