MAUDE Adverse Event Report: SYNTHES GMBH T-PAL SPACER APPLICATOR HANDLE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number 03.812.001

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

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.Initial reporter address line 1: (b)(6).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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during the procedure the surgeon could not open the implant holder.After a few turns, the knob became stuck on the applicator outer shaft and it took a lot of force to open it.There was no impact to the patient.This report involves one (1) t-pal spacer 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.H3, h4, h6: part number: 03.812.001, lot number: 23p7879, manufacturing site: haegendorf, release to warehouse date: 19 february 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the applicat out shaft (part #: 03.812.001, lot #: 23p7879) was returned and received at us customer quality (cq).Upon visual inspection, there was a foreign substance was observed on the threads at the proximal end.It is most likely blood stains as when wiped with a cleaning wipe, it was able to be removed.There were slight nicks/scratches were observed on the device surfaces indicating signs of normal use which would not contribute to the complaint condition.No other issues were identified with the device.Functional test: functional testing of the received device was performed at cq.The outer shaft (03.812.001, 23p7879) was assembled and disassembled with an applicator knob (03.812.004, 52p2035) and the applicator inner shaft (03.812.003, 30p9432) as intended without any issues.The applicator knob and the applicator inner shaft are investigated.Can the complaint be replicated with the returned device(s)? no.A functional test of the returned devices determined the devices to function as intended.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq as the complaint condition could not be replicated and the devices functioned as intended.Document/specification review: the following drawing(s) (current and manufactured to) were reviewed: - applicator handle cpl t-pal no design issues or discrepancies were found during this investigation.Complaint confirmed? no.Investigation conclusion: the complaint cannot be confirmed for the applicat out shaft (part # 03.812.001, lot # 23p7879) as the devices passed the functional test and functioned as intended.However, there was a foreign substance observed on the proximal threads of the device.No definitive root cause can be determined based on the provided information.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 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: T-PAL SPACER APPLICATOR HANDLE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12033084
• MDR Text Key: 257251938
• Report Number: 8030965-2021-05118
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819405813
• UDI-Public: (01)07611819405813
• Combination Product (y/n): N
• PMA/PMN Number: K151276
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.001
• Device Lot Number: 23P7879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APPLICATOR INNER SHAFT; APPLICATOR KNOB; APPLICATOR INNER SHAFT; APPLICATOR KNOB