MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - LOCKING/SET SCREWS: VIPER SAI; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in japan as follows: it was reported that during a surgery performed on (b)(6) 2023, when the surgeon used the approximator fc sleeve to set a rod to a sai screw, the set screw stuck inside the approximator fc sleeve and could not be removed.The surgeon didn't use the approximator fc sleeve in any particular unusual way.The surgeon said that the approximator fc sleeve could have deteriorated over time.The surgery and patient were not affected by this event because there were spare products.The surgery was completed successfully with no surgical delay.The approximator fc sleeve is a long-term consignment.No further information is available.This report is for an unknown viper sai screw.This is report 2 of 2 for (b)(4).

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.G4 - 510k: this report is for an unknown viper screw/unknown lot.Part and lot number are unknown; udi number is unknown.E3: reporter is a synthes employee.H6: the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual investigation of the returned device found that the unk - locking/set screws: viper sai was broken, fragment remained stuck in the approximator fc sleeve.A dimensional inspection for the unk - locking/set screws: viper sai was unable to be performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the unk - locking/set screws: viper sai would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed a document/specification review was not performed since the product code was not received.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: UNK - LOCKING/SET SCREWS: VIPER SAI
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17663415
• MDR Text Key: 322422814
• Report Number: 1526439-2023-01574
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: APPROXIMATOR FC SLEEVE; UNKNOWN RODS