MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5; DRIVER, PROSTHESIS

Model Number	279702000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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) 2020, during inspection it was noticed that the tip of the inserter fell apart and the golden marking of the head positioner was not positioned correctly.It could not be connected to the handle.No surgical involvement.No patient involvement reported.This report is for one (1) expedium spine system single inner inserter 5.5.This is report 2 of 2 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.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the single innie inserter (p/n: 279702000, lot #: gm3799401) was returned and received at us cq.Upon visual inspection, it was observed that the x25 inserter tip and the inserter spring were fell apart from the device.No other issues were observed with the returned device.Functional test: during a functional test, the fell apart components were tried to assemble with the device and there were no issues identified as both the components were able to assemble and disassemble but the spring component was observed to be slightly bent.Dimensional inspection: a dimensional inspection was performed on the returned device.The outer diameter of the x25 inserter tip was measured and is within the specification per relevant drawing.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed investigation conclusion: the complaint condition was confirmed for the single innie inserter (p/n: 279702000, lot #: gm3799401).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.H3, h4, h6: a device history record (dhr) review was conducted: a review of the receiving inspection (ri) for single innie inserter was conducted identifying that lot number gm3799401 was released in a single batch.Batch1: lot qty of 123 units were released on 06 mar 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 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.Investigation flow: device interaction/functional.Visual inspection: the single innie inserter (p/n: 279702000, lot #: gm3799401) was returned and received at us cq.Upon visual inspection, it was observed that the x25 inserter tip and the inserter spring were fell apart from the device.No other issues were observed with the returned device.Functional test: during a functional test, the fell apart components were tried to assemble with the device and there were no issues identified as both the components were able to assemble and disassemble but the spring component was observed to be slightly bent.The complaint can not be replicated with the returned device.Dimensional inspection: a dimensional inspection was performed on the returned device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint was confirmed.The head adjuster marker component of the device received was moved from its original position.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the single innie inserter (p/n: 279702000, lot #: gm3799401).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.Device history lot: a review of the receiving inspection (ri) for single innie inserter was conducted identifying that lot number gm3799401 was released in a single batch.Batch1: lot qty of (b)(4) units were released on mar 06, 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 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: EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10936516
• Report Number: 1526439-2020-02337
• Device Sequence Number: 10908744
• Product Code: HWR
• UDI-Device Identifier: 10705034198408
• UDI-Public: (01)10705034198408
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 11/05/2020

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: 279702000
• Device Catalogue Number: 279702000
• Device Lot Number: GM3799401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 12/30/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/06/2021; 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MMSI HEAD ADJUSTER; UNKNOWN HANDLES; MMSI HEAD ADJUSTER; UNKNOWN HANDLES