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

Catalog Number	03.812.521
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
Additional 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.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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image attached in the email in notes & attachments section of pc titled "rekla.- t pal implantathalter - köln sana dreifaltigkeitskhs.Source doc - not to be translated".The image was reviewed and the complaint condition is not confirmed.The complaint device is not found in the provided photo.The provided photo is a snip from a catalog and it cannot be confirmed that there are any issues with the complaint device.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was provided or found in the photos, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: no valid lot number was provided or found in the photos, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is received.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: surgeon reports 3 identical cases.This captures case 2: after the surgeon had placed the cage he wanted to adjust the placing of the cage.While doing so the inserter removed itself from the cage.Surgeon states that the inserter was definitely not unlocked and the green ring was visible.The cage had then be removed with the revision pliers.No allegation against the revision pliers.This report is for one (1) advanced appl outer shaft.This is report 2 of 4 for complaint (b)(4).
Event or Problem Description
It was further reported that the cage remains implanted.
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, h4, h6: part: 03.812.521.Lot: 5l31716.Manufacturing site: hagendorf.Release to warehouse date: august 16, 2019.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample did not identify any indication of a product defect with advanced appl inner shaft.A dimensional inspection was not performed for the advanced appl inner shaft as no product defect was found after visual examination.A functional test was performed to assemble the outer shaft to the inner shaft and it was successful.The devices assembled tightly, no indication of looseness was detected.The complaint condition was not replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the advanced appl inner shaft would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed current and manufactured revisions were reviewed.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 INNER SHAFT
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13156435
• Report Number: 8030965-2022-00053
• Device Sequence Number: 17138593
• Product Code: MAX
• UDI-Device Identifier: 07612334143785
• UDI-Public: (01)07612334143785
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 03.812.521
• Device Lot Number: 5L31716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2019
• 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 OUTER SHAFT; APPLICATOR KNOB; UNK - CAGE/SPACERS: T-PAL
• Patient Sex: Unknown