MAUDE Adverse Event Report: SYNTHES GMBH T-PAL ADVANCED APPLICATOR HANDLE; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number 03.812.520

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960)

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

Event Date 09/06/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device was 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during tlif surgery, a cage was inserted using new tpal set equipment.When the surgeon tried to disconnect the insertion device he was unable to release the grip from the cage.After multiple attempts the disconnection was successful and the surgery continued as usual.There was a surgical delay of fifteen (15) minutes.The procedure was successfully completed.There was no patient consequence.This report is for one (1) t-pal advanced applicator handle.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.The affected and investigated items show normal wear and tear.There is no abnormal damage (broken or bend) visible.After lubrication according to dai the parts worked as intended without any major problems.Missing lubrication could potentially be the issue which leads to an increased friction in the thread and the small moving components in the outer shaft.According to our procedure the lubrication is an important portion of the reprocessing to ensure proper function of the instruments.It seems that this has not been properly executed.Therefore, no action is required.Device history lot part: 03.812.520, lot: l954903, manufacturing site: hägedorf, release to warehouse date: 05.Oct.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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

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.E1.Initial reporter state: (b)(6).H6: additional codes provided for reporting.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

On (b)(6) 2020: this complaint was created to capture the second time that happened with the specific set in the hospital, while (b)(4) captures the first event.

• Brand Name: T-PAL ADVANCED APPLICATOR HANDLE
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10607381
• MDR Text Key: 209246417
• Report Number: 8030965-2020-07550
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10705034821078
• UDI-Public: (01)10705034821078
• Combination Product (y/n): N
• PMA/PMN Number: K181231
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.812.520
• Device Catalogue Number: 03.812.520
• Device Lot Number: L954903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2020
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVANCED APPL INNER SHAFT; ADVANCED APPL INNER SHAFT; ADVANCED APPL OUTER SHAFT; APPLICATOR KNOB; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL; UNK - CAGE/SPACERS: T-PAL; ADVANCED APPL INNER SHAFT; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL