MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CH EXP 6.35 TI POLY 6 X 50MM; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

Model Number 179912650

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

It was reported by the customer that during a posterior spinal fusion surgery on (b)(6) 2022, it was observed that the head on the screw device broke off.According to the report, the surgeon was attempting to drive the screw deeper in the pedicle, and in the process, the screw head broke off, leaving just the screw shank in the pedicle of the patient.This was at the level of l5 on the left side of the patient.It was reported that the surgeon had to make numerous attempts to remove the broken screw and was ultimately able to do so via hospital provided instrumentation.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.This complaint involves one device.

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A manufacturing record evaluation was performed for the finished device: product code: 179912650.Lot: 251054.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: july 17, 2019.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.D7: it is unknown if this single-use device was reprocessed and reused.

• Brand Name: EXP 6.35 TI POLY 6 X 50MM
• Type of Device: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14272818
• MDR Text Key: 290805278
• Report Number: 1526439-2022-00655
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034086484
• UDI-Public: 10705034086484
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Model Number: 179912650
• Device Catalogue Number: 179912650
• Device Lot Number: 251054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 105 KG