MAUDE Adverse Event Report: SYNTHES USA 1.5MM TI CORTEX SCREW SELF-TAPPING 9MM; MANDIBLE DISTRACTION DEVICES

Catalog Number 400.809.96

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

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 06/06/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient weight not available for reporting.(b)(4) lot unknown.Device not implanted or explanted, parts remain in patient.Device available for evaluation?: date returned to manufacturer.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.Subject device has been received.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 received.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 open reduction internal fixation (orif) of a right meta carpal on (b)(6) 2016, the head of the cortex screw broke upon tightening onto the plate.Several attempts were made but surgeon was unsuccessful to remove the shaft of the screw.Surgeon attempted to implant the second cortex screw at a different angle and screw broke again.In addition, it was reported that it was too invasive to remove the shaft of the second broken screw.Both screw heads were retrieved from patient.Due to this event, surgery was delayed by one (1) hour.Procedure was successfully completed and patient/status outcome was reported as "stable".This complaint involves two parts.Concomitant device: 1.5mm plate, part#446.031, lot#unknown.Quantity (1).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

(b)(6).Product investigation summary: two (2) broken screw heads were received and reported to be part number 400.809.96.The shafts of both screws were broken off and were not returned.Because of this, the reported part number was unable to be confirmed.The returned fragments are approximately 2.5mm in length with a head diameter of approximately 2.95 mm, which is consistent with the reported part number.Although the exact cause for the screw breakage is unknown, it is likely that the screws were being inserted into excessively hard bone.A visual inspection, functional test, and drawing review were performed as part of this investigation with no product design issues or discrepancies observed.The returned devices are part of the 2.0mm locking compression plate and 1.5mm / 2.0mm rotation correction plate sets indicated for repairing fractures and osteotomies of the metacarpals and phalanges.The relevant drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design, materials, and finishing processes were found to be appropriate for the intended use of these devices.The exact cause for the screw breakage is unknown; however, it is likely that the screws were being inserted into excessively hard bone.No new, unique, or different patient harms were identified as a result of this investigation.(b)(4).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: 1.5MM TI CORTEX SCREW SELF-TAPPING 9MM
• Type of Device: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): SYNTHES USA; 1302 wrighjts lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5738700
• MDR Text Key: 47841759
• Report Number: 2520274-2016-13233
• Device Sequence Number: 1
• Product Code: MQN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK981275
• 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: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.809.96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• 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: 21 YR