MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 ELEMENT MIS POLYAXIAL SCREW 6.5X40MM; S4 INSTRUMENTS

Model Number ST063T

Device Problem Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that in preparation of a pedicle for a screw placement, the tip of the trocar shaft broke off in the patient.It broke in two pieces.The surgeon was able to remove the first piece but the second piece he had to push into the vertebra.There was a hour and fifty-seven minute delay in surgery to retrieve the broken piece.All med watch submissions related to this report are: a 9610612-2017-00213, 9610612-2017-00214, 9610612-2017-00215, 9610612-2017-00216, 9610612-2017-00217.

Manufacturer Narrative

The components have been examined visually and microscopically with the digital microscope vhx-5000 keyence and digital camera.We investigated the fracture surface of the fragment.Here we found the typical signs of an inter-crystalline cleavage fracture.Hardness of the fragment was checked and according to specification (49+/-2 hrc) it is in the allowable tolerance with 529 hv (51 hrc).For check we embedded the fragment because otherwise an analysis would not have been possible.Additionally we investigated the instrument fw271r.Here we found a bent tip.A review of the device quality and manufacturing history records is not possible because the batch number is unknown.The root cause of the problem is most probably user related.The hardness is in the allowable tolerance, a manufacturing error can be excluded.Without further knowledge about the circumstance and including the bent tip of fw271r we assume an to high load during surgery as the causal factor.No capa necessary.

• Brand Name: S4 ELEMENT MIS POLYAXIAL SCREW 6.5X40MM
• Type of Device: S4 INSTRUMENTS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: lindsay chromiak ; 615 lambert point drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6538912
• MDR Text Key: 74256585
• Report Number: 9610612-2017-00216
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K090657
• 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: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ST063T
• Device Catalogue Number: ST063T
• Device Lot Number: 52187278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/09/2017
• Device Age: 18 MO
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• 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
• Patient Outcome(s): Other