MAUDE Adverse Event Report: DEPUY SPINE INC TRIAL INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number LET20100

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 an unknown procedure the trial inserters bent.The procedure was successfully completed with the bent trial inserter.They noticed it bent after they had trialed.There was no surgical delay.Patient status is unknown.This report is for one (1) trial inserter.This is report 1 of 3 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.Investigation flow: damage.Visual inspection: the trial inserter (product code: let20100 & lot no: e19di0875) was received at us cq.The visual inspection of the received device indicated that the inserter outer shaft was bent near the distal end and several scratches were observed on the device that were consistent with the normal wear.Thus, the complaint condition was confirmed.Device failure/defect identified? yes.The outer shaft component was bent near the distal end.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device at the distal end.Document/specification review: based on the manufactured date, all related drawings were reviewed.Complaint confirmed? yes.Investigation conclusion: the complaint condition was confirmed for the received trial inserter device as a component in the device was bent near the distal end.While no definitive root cause could be determined based on the provided information, it is possible that the device was 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 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 trial inserter was conducted identifying that lot number e19di0875 was released in a single batch.Batch1: lot qty of (b)(4) units were released on aug 23, 2019 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.

Event Description

Concomitant device reported: implant inserter (part# unknown, lot# unknown, quantity unknown).

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: h4: updated manufacture date 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: TRIAL INSERTER
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10510486
• MDR Text Key: 206350943
• Report Number: 1526439-2020-01631
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557837702
• UDI-Public: 04260557837702
• Combination Product (y/n): N
• PMA/PMN Number: K181644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2020

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: LET20100
• Device Catalogue Number: LET20100
• Device Lot Number: E19DI0875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/07/2020; 10/08/2020
• Supplement Dates FDA Received: 10/08/2020; 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANT INSERTER.