MAUDE Adverse Event Report: DEPUY SPINE INC MOSS MIAMI SPINE SYSTEM POLYAXIAL HEAD POSITIONER 5.5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 279712350

Device Problems Device Markings/Labelling Problem (2911); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2020

Event Type  malfunction  

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 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) moss miami spine system polyaxial head positioner 5.5.This is report 1 of 2 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.Investigation summary.Visual inspection: the mmsi head adjuster (p/n: 279712350, lot #: nw129566) was returned and received at us cq.Upon visual inspection, it was observed that the head adjuster marker was moved from its original position which could have caused the device interaction issue.No other issues were observed with the returned device.Functional test: a functional test was not performed as the returned device was received by itself.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: the length from the tip of the head adjuster shaft to the proximal end of the head adjuster marker was measured and was not within the specification.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Mm si head adjuster assy: complaint confirmed? yes, 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 mmsi head adjuster (p/n: 279712350, lot #: nw129566).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 mmsi head adjuster was conducted identifying that lot number nw129566 was released in a single batch.Batch1: lot was released on 30 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 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.

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 mmsi head adjuster (p/n: 279712350, lot #: nw129566) was returned and received at us cq.Upon visual inspection, it was observed that the head adjuster marker was moved from its original position which could have caused the device interaction issue.No other issues were observed with the returned device.Functional test: a functional test was not performed as the returned device was received by itself.The complaint can not be replicated with the returned device.Dimensional inspection: the length from the tip of the head adjuster shaft to the proximal end of the head adjuster marker was measured.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 mmsi head adjuster (p/n: 279712350, lot #: nw129566).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 mmsi head adjuster was conducted identifying that lot number nw129566 was released in a single batch.Batch1: lot qty of (b)(4) units were released on mar 30, 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: MOSS MIAMI SPINE SYSTEM POLYAXIAL HEAD POSITIONER 5.5
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10936558
• MDR Text Key: 220302582
• Report Number: 1526439-2020-02336
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034198880
• UDI-Public: (01)10705034198880
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/05/2020

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
• Device Operator: Health Professional
• Device Model Number: 279712350
• Device Catalogue Number: 279712350
• Device Lot Number: NW129566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 12/29/2020
• Supplement Dates FDA Received: 01/05/2021; 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SINGLE INNIE INSERTER; UNKNOWN HANDLES