MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC T-PAL SPACER APPLICATOR INNER SHAFT; INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Model Number 03.812.003

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Without a lot number the device history records review could not be completed.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

It was reported that during a transforaminal lumbar interbody fusion (tlif) on (b)(6) 2018, the applicator handle got stuck on the cage while the surgeon was placing a 9mm transforaminal posterior atraumatic lumbar spacer (t-pal) in the l3-l4 disc space.When the cage was in the final position, the surgeon released the applicator handle and it stuck on the cage.The surgeon tried moving the applicator handle side to side and up and down with no success.The surgeon then released the security ring and removed the applicator handle from the inner shaft.His assistant was able to remove it from the shaft, moving it medial/lateral.Procedure was completed successfully with a surgical delay of 20-25 minutes.Patient status is unknown.This report is for a t-pal spacer applicator inner shaft.This is report 2 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.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

Concomitant devices: t-pal cage (part: unknown, lot: unknown, quantity: 1).

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.Device history lot: part: 03.812.003, lot: l286749, manufacturing site: haegendorf, release to warehouse date: 19.Apr.2017.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality investigation: the following investigations were performed: functional.Device condition: visual inspection performed at customer quality observed no issues both visually and functionally when tested.However, the spacer used with the system was not returned.Therefore, the exact complaint condition was not able to be replicated.And with no issues noted on the returned portions of the device, complaint condition was not able to be confirmed.The complaint condition was not able to be confirmed.Document and specification review: document/specification review: the drawings of 3 returned assembly devices, reflecting the current and manufactured revision, were reviewed and no design issues were observed.Dimensional analysis was not performed as no issues were identified with the returned devices during inspection.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Conclusion: a definitive root cause could not be determined from the provided information.However, technique explains to rotate the knob clockwise until the security ring clicks allowing the pivot to implant and then to detach the system by pushing the security ring down and simultaneously turning the applicator knob counterclockwise until it stops.Therefore, it is likely that any unintended improper use/inappropriate steps followed during usage could have contributed to this complaint condition.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 INNER SHAFT
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8200685
• MDR Text Key: 131590461
• Report Number: 2939274-2018-55611
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10705034727790
• UDI-Public: (01)10705034727790
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.812.003
• Device Catalogue Number: 03.812.003
• Device Lot Number: L286749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR