MAUDE Adverse Event Report: SYNTHES GMBH T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT; TEMPLATE

Catalog Number	03.812.511
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 03.812.511, lot: 9931989, manufacturing site: (b)(4), release to warehouse date: 19 august 2016.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the t-pal large trial implant siz 11 non det (part #: 03.812.511, lot #: 9931989) was received at us cq.Upon visual inspection, the distal bold tip of the device was broken off and not returned.Device failure/defect identified? yes.Dimensional inspection: measured dimensions: small shaft od near the tip = conform.Shaft od = conform.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the distal bold tip has broken off.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that after inserting the trial cage, when taking the trial out, the trial was left in the patient.The trial was removed from the patient.There was a surgical delay.Concomitant device reported: unknown insertion instrument (part# unknown; lot# unknown; quantity: 1).This report is for one (1) t-pal trial spacer 12mm x 32mm 11mm height.This is report 1 of 1 for (b)(4).

• Brand Name: T-PAL TRIAL SPACER 12MM X 32MM 11MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12353196
• Report Number: 8030965-2021-07037
• Device Sequence Number: 3974022
• Product Code: HWT
• UDI-Device Identifier: 07611819420724
• UDI-Public: 07611819420724
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2021

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 Catalogue Number: 03.812.511
• Device Lot Number: 9931989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/23/2021
• 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: UNKNOWN INSERTION INSTRUMENTS