MAUDE Adverse Event Report: SYNTHES GMBH T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT; TEMPLATE

Model Number	03.812.310
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that the device broke inside its insertion handle becoming unusable during an ppen degen surgery of the l5 s1.The instruments were assembled without difficulties.After the test of the cage was carried out and after it was removed from the patient, when the instrument was disassembled, it was verified that the internal shaft of the test came out without the back.The same was inside the metallic handle that was later removed.The episode was intraoperatively but without patient involvement.This report is for one (1) t-pal trial spacer 10mm x 28mm 10mm height.This is report 1 of 1 for (b)(4).

• Brand Name: T-PAL TRIAL SPACER 10MM X 28MM 10MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12319363
• Report Number: 8030965-2021-06655
• Device Sequence Number: 4447938
• Product Code: HWT
• UDI-Device Identifier: 10705034727851
• UDI-Public: 10705034727851
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2021

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 Model Number: 03.812.310
• Device Catalogue Number: 03.812.310
• Device Lot Number: 7737851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1