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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in south africa as follows: it reported that (b)(6) 2023, that a deformity was booked by prof.The child had surgery a few year ago, growing rod surgery for deformity.The planned procedure was for a t1-l3 deformity correction.This could generally include somewhere in the region of 20+ screws.Upon receipt of shortages late the night before the case, i was informed that there is only 9 caps on the set.Each screw inserted will need a cap, thus 20 screws would need 20 caps.Because we were not made aware of these critical shortages on the set, and surgery had to continue as it is planned well in advance and the patient traveled from far, postponing or cancelling was not an option.We were only able to inform the surgeon of these critical shortages early in the morning on the day of surgery.The surgeon was forced to deviate from his surgical plan and was not able achieve the correction required.This patient will have to go for further surgery in the future because of this.There was patient outcome/consequences.The deformity correction was not able to be performed.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes.Future procedures will be needed.This report is for one (1) unk - locking/set screws: expedium this is report 11 of 11 for complaint (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.This report is for an unk - locking/set screws: expedium/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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.

• Brand Name: UNK - LOCKING/SET SCREWS: EXPEDIUM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16524772
• MDR Text Key: 311128588
• Report Number: 1526439-2023-00477
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Sex: Male