MAUDE Adverse Event Report: DEPUY SPINE INC TRIAL INSERTER SH CONNECTION; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number TFT20101

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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

Device report from (b)(6) reports an event as follows: it was reported that during a procedure on an unknown date, the inner shaft of the conduit tlif trial inserter broke off while trying to release/remove the trial implant.Procedure was completed successfully with no delay.There was no impact on the patient.This report is for a trial inserter sh connection.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).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: d4: lot number provided for reporting.D9: the device has been received.D11: concomitant products added.H3, h4, h6, device history lot.Part # tft20101.Synthes lot # e19di1432.Supplier lot # e19di1432.Release to warehouse date: 02 jun 2020.Supplier: eit.No ncr's were generated during production.Device history batch null, 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.H6: investigation summary: background: conduit tlif trial inserter : the inner shaft of the trial inserter broke off while trying to release/remove the implant trial.No impact on the patient.No impact on the surgery.09/28/2020: update ed: concomitant device reported: unknown trials(part# unknown, lot# unknown, quantity unknown ).This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the trial inserter sh connection (p/n: tft20101, lot #: e19di1432) was returned and received at us cq.Upon visual inspection, the proximal end of the tft20101 c tlif trial inserter pin sh connection component was observed to be broken.The broken fragment was stuck inside the trial inserter and the inserter knob assembly due to which knob (p/n: tft20101 b) was not able to disassemble from the inserter (p/n: tft20101 a).There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned components of the device.Device failure/defect was identified.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 device received condition.Document/specification review following drawing was reviewed.Tft20101 trial inserter sh connection: 12028.03.320, rev.D.Complaint was confirmed.The device received was broken.Hence confirming the allegation.Investigation conclusion.The complaint condition was confirmed for the trial inserter sh connection (p/n: tft20101, lot #: e19di1432).There is no indication that a design or manufacturing issue has caused the complaint condition 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.D4: lot number provided for reporting.

• Brand Name: TRIAL INSERTER SH CONNECTION
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10697203
• MDR Text Key: 211886944
• Report Number: 1526439-2020-01988
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 04260557775578
• UDI-Public: (01)04260557775578
• 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
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TFT20101
• Device Catalogue Number: TFT20101
• Device Lot Number: E19DI1432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 11/05/2020
• Supplement Dates FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAL INSERTER SH CONNECTION; UNK - TRIALS; UNK - TRIALS; UNK - TRIALS
• Patient Age: 59 YR