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

Catalog Number	03.812.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
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.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during a transforaminal lumbar interbody fusion (tlif) procedure with matrix screws and transforaminal posterior atraumatic lumbar (tpal) cage, both inserters failed to engage with the shaft of the trials making it difficult for them to straighten and stiffen the trials.The applicator knob came off from the inserter when attempting to tighten the trial.The procedure was completed by exchanging the knobs of the applicators.There was a surgical delay greater than fifteen (15) minutes.There is no further information available.Concomitant devices reported: unknown matrix screws (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) t-pal spacer applicator handle.This is report 5 of 6 for (b)(4).
Event or Problem Description
Concomitant devices: unknown matrix screws (part# unknown, lot# unknown, quantity# unknown).Unknown cage/spacers: t-pal (part# unknown, lot# unknown, quantity# 1).
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: b5.D11.H6: reviewing attached picture, the complaint description can be confirmed that the threaded part of these tpal-instruments are damaged.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: T-PAL SPACER APPLICATOR HANDLE
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10408780
• Report Number: 8030965-2020-06004
• Device Sequence Number: 2567407
• Product Code: MAX
• UDI-Device Identifier: 07611819405813
• UDI-Public: (01)07611819405813
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APPLICAT OUT SHAFT.; APPLICATOR INNER SHAFT.; APPLICATOR INNER SHAFT.; APPLICATOR KNOB.; APPLICATOR KNOB.; UNK - CAGE/SPACERS: T-PAL.; UNK - LOCKING/SET SCREWS: MATRIX.; UNK - LOCKING/SET SCREWS: MATRIX.; APPLICAT OUT SHAFT; APPLICATOR INNER SHAFT; APPLICATOR INNER SHAFT; APPLICATOR KNOB; APPLICATOR KNOB; UNK - LOCKING/SET SCREWS: MATRIX