MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X16; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	1020-35-116
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, during posterior spinal fusion surgery while inserting screw in lateral mass of c4, the shaft of screw broke off in the bone.They tried to put new screw beside broken screw but it didn¿t work.Fragments were generated but were not removed.There was a surgical delay of fifteen (15) minutes.There were no patient consequences.The procedure was successfully completed.This complaint involves one (1) device 4.0 ply scrw 3.5x16.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional narrative: 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.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.
Additional 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.D9.Date device returned to manufacturer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the screw head was broken and fully separated from the screw main body.Only the screw head was returned for analysis.The embedded device condition cannot be confirmed since x-ray evidence was not provided.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A manufacturing record evaluation was performed for the finished device [316823] number, and no non-conformances were identified.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 device 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: no design issues or discrepancies were identified.Device history lot - a manufacturing record evaluation was performed for the finished device: product code: 102035116; lot number: 316823.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 10.07.2021.Qty: (b)(4).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: 4.0 PLY SCRW 3.5X16
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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 ; SZ ; 6103142063
• MDR Report Key: 13536191
• Report Number: 1526439-2022-00221
• Device Sequence Number: 4063934
• Product Code: KWP
• UDI-Device Identifier: 10705034508702
• UDI-Public: (01)10705034508702
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1020-35-116
• Device Catalogue Number: 102035116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENTS
• Patient Age: 60 YR
• Patient Sex: Male