MAUDE Adverse Event Report: SYNTHES USA TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM; BONE PLATE

Catalog Number 400.834S

Device Problem Break (1069)

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

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device broke intra-operatively and was not implanted / explanted.(b)(6).Without a valid lot number the device history records review could not be completed.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Device report from synthes gmbh reports an event in (b)(6) as follows: during resection of a brain lesion two (2) screws broke.The broken pieces did not fall into the patient.A new screw was used to complete the procedure.There was no report on patient injury.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device investigation summary: only the screw heads of two unknown 400.8xx screws were received.The complete lengths of the threaded shafts broke off and are missing.The provided part and lot number combination as per device report is unknown (part 400.835s / lot 9377495).Due to the unknown combination, it is not possible to review the device history records.The remaining heads do not show damage or wear.The fracture surfaces are homogenous what indicates for material conformity.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.It is not able to be determined the exact reason for the reported problem, but it is likely that a short time overloading led to the breakage.One possible explanation for such an overloading may be contact with very hard bone or with metal.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

Additional information: surgery was not prolonged.

• Brand Name: TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5289022
• MDR Text Key: 33267295
• Report Number: 2520274-2015-17799
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK022012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.834S
• Device Lot Number: 9377495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1