MAUDE Adverse Event Report: AESCULAP AG S4 POLYAXIAL SCREW 8.5X55MM CANULATED; BONE-SCREW

Model Number	SW378T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: on-going.Please note that the initial mdr dated 10/09/2015, was not submitted and follow up was submitted on 02/05/2018.Per request of the fda the initial has been submitted.
Event or Problem Description
It was reported that there was an issue with s4 polyaxial screw 8.5x55mm canulated.According to the complainant, during procedure screw detached into two parts.The screw could not be removed from the bone, was only able to be removed with a screwdriver.There had been a 8-10 minutes op time extension, the result was successful and there was no patient harm.The complaint devices are available to be return to the manufacturer for evaluation.The adverse event / malfunction is filed under reference (b)(4).

• Brand Name: S4 POLYAXIAL SCREW 8.5X55MM CANULATED
• Common Device Name: BONE-SCREW
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nadine schweikart ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7238455
• Report Number: 3005673311-2015-00157
• Device Sequence Number: 3172308
• Product Code: NKB
• UDI-Device Identifier: 04046963319328
• UDI-Public: 4046963319328
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: SW378T
• Device Catalogue Number: SW378T
• Device Lot Number: 51840151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2015
• Supplement Date Received by Manufacturer: 06/26/2015
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 02/02/2018
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown