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

Catalog Number 201.932

Device Problem Break (1069)

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

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Patient¿s identifier and weight are not available for reporting.(b)(4).Device broke intra-operatively and was not fully implanted or explanted.Without a lot number, the device history record review could not be requested.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 reported that two screws broke off in patient¿s mandible during an intermaxillary fixation (imf) procedure for a mandible fracture on (b)(6) 2017.The screws broke midshaft while surgeon was twisting screw during insertion.The two screw heads and half of the shafts were removed; half of the two shafts remained in the patient's anterior mandible.There were unanticipated x-rays, but no additional medical intervention.The procedure was successfully completed with no delay, no additional issues and good patient outcome.No additional information is available.Concomitant devices: drill (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 2.0mm imf screw self-drilling 12mm.(b)(4).

Manufacturer Narrative

A product investigation was performed.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 tips of the screws were sheared off and were not returned.Approximately 9mm is missing from the tip of each 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 both returned screws.Both screws tested as a match for ss 316.The element percentage ranges were determined to be within the specifications outlined per the relevant 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.The relevant drawings were reviewed during investigation.The design history was not found to impact the complaint condition.The minor thread diameters of the returned screws were measured adjacent to the breakage.The minor diameters measured within the specification.No definitive root cause was able to be determined.The screw breakage could be related to excessively hard bone, the technique guide indicates "in dense cortical bone it may be necessary to predrill." during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 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: 6952173
• MDR Text Key: 90549639
• Report Number: 1719045-2017-11068
• 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: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• 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: 10/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR