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

Catalog Number	03.812.001
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
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.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, the applicator shaft and knob blocked when timing up and in to prepare for the pick-up of the inner shaft.The surgery was completed without delay.No adverse patient consequences.This complaint involves two (2) devices.This report is for (1) t-pal spacer applicator handle.This report is 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4, d7 h3, h4, h6: a manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure, no manufacturing record evaluation is required.The device was manufactured on september 27, 2017.Visual inspection: the applicat out shaft was received at us customer quality (cq).Visual inspection of the complaint device showed no damage.Functional test: a functional assessment was performed on the complaint device and the returned mating device.The devices were able to assemble and disassemble smoothly, without binding or getting stuck.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as no damage was observed and the complaint device assembled and disassembled smoothly with mating device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.D9.

• Brand Name: T-PAL SPACER APPLICATOR HANDLE
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11057079
• Report Number: 8030965-2020-09914
• Device Sequence Number: 2684445
• Product Code: MAX
• UDI-Device Identifier: 07611819405813
• UDI-Public: (01)07611819405813
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 03.812.001
• Device Lot Number: L475754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APPLICATOR KNOB