MAUDE Adverse Event Report: DEPUY SPINE INC IMPLANT INSERTER; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number AET30100

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is company representative.Without a lot number, the device history records review could not be completed as no product was 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that one of the inner shafts of an implant inserter is not threading on to the wheel.Indeed, both of the implant inserters are fully functioning.One of the tips of one of the yellow handle trial implant inserters (aet20101) is slightly bent.The damage was discovered during the inspection.The other trial implant inserter is in perfect condition.It was unknown if the surgery completed successfully.There were no patient consequences are reported.Concomitant device reported: unknown conduit cage alif (part# unknown, lot# unknown, quantity unknown); unknown implant inserter connection eit (part# unknown, lot# unknown, quantity unknown); unknown implant inserter (part# unknown, lot# unknown, quantity 2); this complaint involves five(5) devices.This report is for (1) implant inserter.This is report 4 of 5 for (b)(4).

Event Description

Updated event description: concomitant device reported: unknown conduit cage alif (part# unknown, lot# unknown, quantity unknown).Unknown implant inserter connection eit (part# unknown, lot# unknown, quantity unknown).Implant inserter (part# aet30100, lot# e16di0200, quantity 1).

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: b5: updated event description.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

The initial complaint was reviewed and found not reportable.It was determined the part is a sub-component of another reported device and is already captured on report 1526439-2020-01267.

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.H11: b1, b5, h1: the initial complaint was reviewed and found not reportable.It was determined the part is a sub-component of another reported device and is already captured on report 1526439-2020-01267.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: IMPLANT INSERTER
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10196510
• MDR Text Key: 197149603
• Report Number: 1526439-2020-01269
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260397082218
• UDI-Public: (01)04260397082218
• Combination Product (y/n): N
• PMA/PMN Number: K172888
• 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: 06/15/2020

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: AET30100
• Device Catalogue Number: AET30100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 07/31/2020
• Supplement Dates FDA Received: 07/27/2020; 08/10/2020
• Patient Sequence Number: 1
• Treatment: HAMMER; HAMMER; IMPLANT INSERTER SH CONNECTION; TRIAL INSERTER SH CONNECTION; TRIAL INSERTER SH CONNECTION; UNKNOWN CAGE/SPACER; UNKNOWN CAGE/SPACER; UNKNOWN INSERTION INSTRUMENTS; UNKNOWN INSERTION INSTRUMENTS