MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 179702000

Device Problem Crack (1135)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a procedure while inserting the screws, the screw threads were peeled.Another new screws were used to complete the surgery.No adverse consequences to the patient.Concomitant device reported: unknown insertion instrument (part# unknown, lot# unknown, quantity unknown).This report is for one (1) single-inner setscrew.This is report 1 of 1 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.H10 additional narrative: h3, h4, h6: a manufacturing record evaluation was performed for the finished device product code: 179702000 lot number: 280444 it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 08.06.2020 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.

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12892017
• MDR Text Key: 286243732
• Report Number: 1526439-2021-02480
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• 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: 280444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• 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: UNKNOWN INSERTION INSTRUMENTS