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

Catalog Number	03.812.520
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during the cleaning procedure it was noticed that the instrument cannot be disassembled.There was no impact to patient or surgery.This report involves one (1) t-pal advanced applicator handle.This is report 2 of 3 for (b)(4).
Additional 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, h6: part number: 03.812.520, lot number: 29p8785, manufacturing site: haegendorf, release to warehouse date: june 8, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the advanced appl outer shaft (part# 03.812.520, lot# 29p8785 qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.No other issues were identified with the device.Functional test: a functional test was performed on the returned devices.The knob was turned counter-clockwise in the open direction until it contacted the security ring and the push to release button arrow aligned with the detach implant arrow on the security ring.The push to release button was then pressed and the applicator inner shaft was removed from the assembly.The knob was then rotated clockwise in the close direction until it disassembled from the threaded end of the applicator handle with no difficulty.No signs of any damage were observed on the threads.The devices function as intended.The applicator knob and the applicator inner shaft are investigated separately.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 advanced appl outer shaft (part# 03.812.520, lot# 29p8785 qty# 1) as the devices passed the functional test and functioned as intended.While a definitive root cause could not be identified for the reported issue, it is possible that the surgical technique for the disassembly of the devices was not followed appropriately.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 upon these results, 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 ADVANCED APPLICATOR HANDLE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12377185
• Report Number: 8030965-2021-07256
• Device Sequence Number: 14557584
• Product Code: MAX
• UDI-Device Identifier: 07612334143778
• UDI-Public: (01)07612334143778
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.812.520
• Device Lot Number: 29P8785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVANCED APPL INNER SHAFT; APPLICATOR KNOB; ADVANCED APPL INNER SHAFT; APPLICATOR KNOB
• Patient Sex: Unknown