MAUDE Adverse Event Report: SYNTHES USA TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 400.833

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.Additional narrative:patient information is not available for reporting- although patient gender is not specified by reporter it is noted in the description.(b)(6).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.If info 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 (b)(4) reports an event in (b)(6) as follows: it was reported that during an unknown procedure (8) eight screws broke while being inserted into the patient.All broken screw parts were retrieved from the patient.The unknown procedure was prolonged 15 to 20 minutes due to this incident.The procedure was completed by using other screws of the same size.There was no reported harm to the patient, he is doing well.This is report 3 of 8 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).(b)(6).The subject device has been received and is currently in the evaluation process.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 was received (b)(6) 2015, when the complained devices were received by the manufacturer for evaluation.Eighteen (18) screws were received with the complaint of broken during insertion during an unknown surgical procedure, not eight (8) as previously reported.This report is 3 of 18 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Device investigation summary ¿ the complaint condition for the three (3) 400.833 3mm titanium low profile neuro screws, one (1) 4mm titanium low profile neuro screws, ten (10) 5mm titanium low profile neuro screws, and four (4) 6mm titanium low profile neuro screws with unknown lot numbers was likely caused by not drilling prior to screw insertion; however, this complaint is not likely a result of any design related deficiency.Eighteen screws were returned, sixteen of which are broken and two of which appear to be intact.The part numbers for one intact 400.834 4mm titanium low profile neuro screw and one intact 400.836 6mm titanium low profile neuro screw can be confirmed through measurement, but the remaining broken screws cannot.The sixteen broken screws will be assumed to be the part numbers as reported.The eighteen titanium low profile neuro screws are implants routinely used in the low profile neuro plating system.The screws were returned and reported to have broken during insertion.This condition is confirmed; twelve screws are broken along the shaft and four screws have broken or are significantly deformed at the very distal self-drilling tip of the screw.It is likely that the surgeon did not drill prior to insertion which may have led to this complaint condition.The bone where the screws were to be inserted may also have been particularly dense.The condition of the returned screws is consistent with attempted insertion.Device drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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: TI LOW PROFILE NEURO SCREW SELF-DRILLING 3MM
• 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: 5173893
• MDR Text Key: 29841337
• Report Number: 2520274-2015-16799
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK031807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400.833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1