MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONN O/C ANGLD 5.5-6.35X5.5TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179774555
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional procode: kwp;kwq;mnh;mni;osh.Reporter is a j&j employee.The device was 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the connector was found to have come loose.The issue was found during sterilization.There was no patient involvement.This report is for one (1) conn o/c angld 5.5-6.35x5.5ti.This is report 1 of 1 for (b)(4).
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.H10: additional narrative: a review of the receiving inspection (ri) for conn o/c angld 5.5-6.35x5.5ti was conducted identifying that lot number nw238708 was released in a single batch on february 19, 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A product investigation was completed: visual inspection of the complaint device showed the cap component fall apart and was not attached with the remainder device.No other defect was observed.A functional assessment was not performed with the complaint device since one component was not attached.The component was not able to be re-inserted back into place.No dimensional inspection was performed due to requiring destruction of the device, and device assembly and geometry limits the ability to accurately dimensionally inspect the device.The current and manufactured to drawing was reviewed; no design issues or discrepancies were identified.This complaint is confirmed.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety 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.

• Brand Name: CONN O/C ANGLD 5.5-6.35X5.5TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12366512
• Report Number: 1526439-2021-01755
• Device Sequence Number: 14424988
• Product Code: NKB
• UDI-Device Identifier: 10705034078120
• UDI-Public: 10705034078120
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 179774555
• Device Catalogue Number: 179774555
• Device Lot Number: NW238708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1