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

Model Number TFT30101

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has been 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.

Event Description

It was reported that on (b)(6) 2020, the conduit inserter found bent after it came through the wash after a spinal fusion case.The inserter was not used during the case.There was no known patient involvement reported.This report is for one (1) implant inserter sh connection.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

H10 additional narrative: h3, h6: a review of the receiving inspection (ri) for implant inserter sh connection was conducted identifying that lot number e19di0731 was released in two (2) batches: -batch1: lot qty of (b)(4) units were released on november 19, 2007 with no discrepancies.-batch 2: lot qty of (b)(4) units were released on june 12, 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.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual inspection: the implant inserter sh connection pin (part #: tft30101 and lot #: e19di0731) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the proximal end of the device was bent, and the threaded portion was slightly stripped.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed tft30101 implant inserter sh connection.Complaint confirmed? yes.Investigation conclusion the complaint condition is confirmed for the implant inserter sh connection pin (part #: tft30101 and lot #: e19di0731).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 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 SH CONNECTION
• 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: 10460249
• MDR Text Key: 204569502
• Report Number: 1526439-2020-01537
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557775592
• UDI-Public: (01)04260557775592
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFT30101
• Device Catalogue Number: TFT30101
• Device Lot Number: E19DI0731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1