MAUDE Adverse Event Report: SYNTHES GMBH UNK - LOCKING/SET SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Material Integrity Problem (2978); No Apparent Adverse Event (3189)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that a posterior lumbar interbody fusion (plif) was performed on (b)(6) 2023.When final tightening, torque was not applied to the sfx cross connector even though the surgeon tightened with considerable force.After many attempts to tighten, the set screw of the sfx cross connector got stripped, and the sfx cross connector could not be removed.The surgery was completed successfully within a 30-minute delay, and the patient status/outcome was reported to be stable.The tip of the sfx torque driver shaft may have been stripped.This complaint is related to (b)(4), which captures additional devices used in the surgery.This report involves one unk - locking/set screws.This is report 1 of 1 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.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 - 510k: this report is for an unknown locking/set screws/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: initial reporter facility name: (b)(6) hospital.E3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.

Event Description

The initial complaint was reviewed and found not reportable.Upon further review it was identified that the reported product is depuy spine product and is captured under related complaint (b)(4).

• Brand Name: UNK - LOCKING/SET SCREWS
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16961135
• MDR Text Key: 315548041
• Report Number: 8030965-2023-06365
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROD Ø5.5 SOFT CURV L70 TI; SFX TORQUE HANDLE; SFX X20 TORQUE DRIVER SHAFT; SFX,5.5,TI, MED, SIZE A6