MAUDE Adverse Event Report: DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T; EXPEDIUM SPINE SYSTEM

Model Number 179771555

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Additional pro-codes: 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 conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 by the loan kit technician during loan kit inspection that the locking screw has come away from the instrument.Making it unusable.No further information can be obtained as the case was not reported by the customer.This complaint involves one (1) device this report is 1 of 1 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.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.

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).H3: correction.H6: additional information.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.Upon visual inspection, it is observed that the m7 short screw was separated and missing from the device assembly.The rest of the device shows minimal wear which would not contribute to the complaint condition.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.A visual inspection, dimensional inspection, and document/ specification review were performed as part of this investigation.The complaint cannot be confirmed.A definitive root cause could not be determined for the reported problem.No product design or manufacturing issues were identified, and no new malfunctions were identified either.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.

• Brand Name: CONN O/O SD TOP NTCH 5.5X5.5 T
• Type of Device: EXPEDIUM SPINE SYSTEM
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9416944
• MDR Text Key: 185301660
• Report Number: 1526439-2019-52585
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077819
• UDI-Public: (01)10705034077819
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179771555
• Device Catalogue Number: 179771555
• Device Lot Number: NW176120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 01/07/2020
• Patient Sequence Number: 1