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

Catalog Number 201.932E

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

Patient (b)(6).Device broke during insertion; device not considered implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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 by a sales consultant that patient was involved in an automobile accident and underwent an open reduction and internal fixation (orif) for a mandible fracture on (b)(6) 2015.It was reported that three screws broke upon implantation.The shafts of the three screws were left in the bone.Two of the 2.0mm imf screw self-drilling 12mm screws heads were able to be retrieved.The head of the third screw, the 2.0mm ti matrixmandible screw self-drilling/locking/8mm was unable to be located.The surgeon used two extra screws that were readily available.There was a surgical delay of about five to ten (5-10) minutes.The surgery was completed successfully.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (2.0mm imf screw, self-drilling, 12mm (reported part number 201.932e, lot number unknown) was returned for the complaint condition ¿broken intraoperatively¿.It was reported that the shaft of the screw was left in the patient¿s bone.Evaluation shows that this implant is part of the intermaxillary fixation (imf) screw set which is ¿intended for indirect stabilization of the maxilla and mandible following craniofacial and mandibular trauma or reconstruction.¿ this information is provided per the imf screw set technique guide.The returned screw was received with the distal threads missing.The returned portions measure approximately 9.6mm in length.Therefore, based on drawing 201.928 rev.B, the estimated length of the missing threaded portion is 8.65mm +0.5/-0.The fracture site was examined and no material voids or irregularities were identified.The edges of the cruciform drive show slight wear consistent with use and the balance of the implant is in working condition.Thus, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the screw is already broken.The lot number is unknown therefore design revisions are unknown.A review of the current design drawing and the revision history was performed.The design history was found to not impact the complaint condition.The screw is manufactured of extra hard 316l stainless steel to provide sufficient strength and mechanical testing demonstrated that the failure torque in longest length screws exceeded the insertion torque by a factor of 1.5 or greater.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The complaint condition is consistent with the result from mechanical overload during the insertion.The imf surgical technique guide suggests pre-drilling dense cortical bone and taking care to avoid the tooth roots because inserting screws without doing so can result in increased insertion torque and cause screw failure.Thus, the complaint condition is most likely the result of the method of use.However, as the specific circumstances at the time of the break and the user technique are unknown, the root cause cannot be definitively determined.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 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: 5189070
• MDR Text Key: 29890012
• Report Number: 2520274-2015-16922
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.932E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2015
• 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: 35 YR
• Patient Weight: 109