MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONN O/O SD TOP NTCH 6.35X5.5; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179771655
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code : kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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
It was reported that on (b)(6) 2021, during an unknown procedure the surgeon was extending an existing construct that had been placed in levels l4-s1 back in 2014.Upon removing the crosslink, attempted to place the rode to rod connector to the existing construct.As drove the set screw into place, a slight clicking sound was noticed and that the final tightener lost resistance.Upon inspection, it was noticed that the implant had cracked.He removed the implant and successfully replaced it with another without any issue.There were no fragments left in the patient and the loss of time in the surgery was less than 5 minutes.The remainder of the revision surgery and tlif spacer placement went forward without incident or any harm to the patient.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).Unknown setscrew (part# unknown, lot# unknown, quantity unknown).Unknown trans connector (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) conn o/o sd top notch 6.35x5.5.This is report 1 of 2 (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: h3, h6: a product investigation was completed: upon visual inspection, it is observed that the wall of the short setscrew hole in the connector component of the device got broken.Broken part is still attached and not separated.Rest of the surface of the device looks good without any damage.Thus, the complaint is being confirmed.Dimensional inspection of the relevant features of the received device was not performed due to the geometry of the device.The relevant drawing was reviewed; no design issues or discrepancies were found during this investigation.The complaint is being confirmed as the wall of the short setscrew hole in the connector component of the device got broken.While a definitive root cause could not be identified for the reported problem, it is possible that the device might have encountered unintended forces.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 upon these results, 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.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.H3, h6: 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.
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.H10 additional narrative: the implant(s) was not returned, and the investigation will be completed based on the supplied image(s) located in pc's attachments section received through 28jan2021.The image(s) was reviewed, and the complaint condition(s) of was confirmed as one end of the implant is cracked resulting in the complaint condition.As the implant(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was performed and no issues were noted.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: a review of the receiving inspection (ri) for conn o/o sd top ntch 6.35x5.5 was conducted identifying that lot number nw144391 was released in a single batch.Batch1: lot qty of units were released on 24 oct 2013 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.Device history batch: null.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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/O SD TOP NTCH 6.35X5.5
• 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: 11323534
• Report Number: 1526439-2021-00285
• Device Sequence Number: 3247628
• Product Code: NKB
• UDI-Device Identifier: 10705034077826
• UDI-Public: 10705034077826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/25/2021

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: 179771655
• Device Catalogue Number: 179771655
• Device Lot Number: NW144391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 03/15/2021; 03/16/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 02/18/2021; 03/16/2021; 03/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWDRIVERS; UNKNOWN TRANSCONNECTOR
• Patient Age: 70 YR