MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 1020-35-116S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/03/2022

Event Type  Injury  

Manufacturer Narrative

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), 2022, the surgeon was performing posterior surgical fusion procedure using the symphony system.Two of the 3.5mm x 16mm lateral mass screws broke just below the head during insertion.It was reported that they broke during the final rotation during insertion without any off axis movement of the driver.The fragments were left in the patient.There was a twenty minute surgical delay.This report is for one (1) symphony oct system polyaxial screw diameter 4.0 rod, 3.5x16mm 3.5 and 4.0.This is report 1 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.H6: the subject 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

There was no adverse effect to the patient.

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.H10 additional narrative: h3, h6: a manufacturing record evaluation was performed for the finished device.Product code: 102035116s, lot: 317004, was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: july 15, 2021.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 4.0 ply scrw 3.5x16 was broken at the base of the threaded shaft.The broken shaft of the screw was not returned.No other issues were identified.The embedded device condition reported could not be confirmed as no postoperative radiographic images were provided.No new additional information can be added after reviewing the received images.The dimensional inspection was performed and the device met specifications.The observed condition of the 4.0 ply scrw 3.5x16 was consistent with a random component failure that may have been caused by exposure to excessive/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 4.0 ply scrw 3.5x16 was observed to be broken.While no definitive root cause could be determined from the available information, it is probable that the 4.0 ply scrw 3.5x16 was broken due to the exposure to excessive/unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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: the following drawings reflecting the current and manufactured revisions were reviewed: 103140293 polyscrew, 4.0 rod, 3.5x08-50.103140293 std shank, 3.5x08-50.Dimensional inspection: measured dimensions: minor shaft diameter (at the base): conforming.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: SYMPHONY OCT SYSTEM POLYAXIAL SCREW DIAMETER 4.0 ROD, 3.5X16MM 3.5 AND 4.0
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13667720
• MDR Text Key: 286580771
• Report Number: 1526439-2022-00336
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 10705034524382
• UDI-Public: (01)10705034524382
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1020-35-116S
• Device Catalogue Number: 102035116S
• Device Lot Number: 317004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 4.0 PLY SCRW 3.5X16; UNKNOWN SCREWDRIVERS
• Patient Outcome(s): Required Intervention