MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 SET SCREW CANULATED; MPLANTS POSTERIOR STABILISATI

Model Number SW375T

Device Problem Failure To Adhere Or Bond (1031)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).During the procedure to repair the fracture the thread was twisting in the monoaxial screws.In the final locking the screws would not hold.The thread was removed and the screws had to be changed.Delay in surgery: one hour.All med watch submissions related to this report are: 3005673311-2016-00203, 3005673311-2016-00204, 3005673311-2016-00205.Components in use listed as concomitant devices are: st485t / element monoax.Allignment.Screw 7.5x50mm (qty 2).

Manufacturer Narrative

Investigation: used test and analysis equipment: microscope "keyence- vhx 5000"; digital-camera "panasonic dmc tz8.We made a visual inspection of the three set screws (sw375t - a-c) and the two pedicle screws (st485t - a & b).The set screws show the typical signs of cross threading like shared off thread or damaged initial thread.Through cross threading the set screw, the thread of the pedicle screw was damaged too.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.Conclusion and root cause: the root cause for the failure is most probably user related.Rational: the problem was caused by cross treading the set screws by screwing into the pedicle screws.Corrective action: according to (b)(4), there is no capa necessary.

• Brand Name: S4 SET SCREW CANULATED
• Type of Device: MPLANTS POSTERIOR STABILISATI
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6176650
• MDR Text Key: 62468141
• Report Number: 3005673311-2016-00204
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW375T
• Device Catalogue Number: SW375T
• Device Lot Number: 52224569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/17/2016
• Device Age: 8 MO
• Date Manufacturer Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ST485T / ELEMENT MONOAX.AUGMENT.SCREW 7.5X50MM; ST485T / ELEMENT MONOAX.AUGMENT.SCREW 7.5X50MM; SW375T / S4 SET SCREW CANULATED; SW375T / S4 SET SCREW CANULATED; SW375T / S4 SET SCREW CANULATED
• Patient Outcome(s): Other