MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179702000

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Kwp; kwq; mnh; mni; osh.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Event Description

It was reported that on (b)(6) 2019, during an unknown procedure, the surgeon was attempting to final tighten an expedium 5.5 set screw on a connector from the universal connector set using the torque limiting driver.Upon doing so the set screw shredded in the connector causing him to have to replace the implant with a new one.There was no harm to the patient.There was no surgical delay.Fragments were generated and were easily removed.There were no patient consequences.The procedure was successfully completed.Concomitant device reported: unknown torque devices (part# unknown, lot# unknown, quantity unknown).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Udi:(b)(4).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.The single-inner setscrew was received with the threads stripped.Some of the threads from the setscrew broke off and are lodged in the connector¿s threads and cannot be separated.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.

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.The single-inner setscrew (part # (b)(4), lot # 248982, mfg # ((b)(6) 2019) was received at us cq with the threads stripped.Some of the threads from the setscrew broke off and are lodged in the connector¿s threads and cannot be separated.This is consistent with the reported complaint condition, thus confirming the complaint.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: the dhr of product code (b)(4), lot 248982, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on (b)(6) 2019.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: SINGLE-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9398481
• MDR Text Key: 197800135
• Report Number: 1526439-2019-52546
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 179702000
• Device Lot Number: 248982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Date Manufacturer Received: 12/23/2019
• Patient Sequence Number: 1
• Treatment: UNKNOWN TORQUE DEVICES
• Patient Age: 61 YR