MAUDE Adverse Event Report: SYNTHES GMBH T-PAL TRIAL SPACER 10MM X 28MM 7MM HEIGHT; TEMPLATE

Catalog Number 03.812.307

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The complaint condition that the proximal ball of the trial implant is broken could be confirmed according to the received pictures.The applicator outer shaft is not visible on the received pictures.Therefore, the complaint condition of this instrument will be rated as n/a.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 history lot: part: 03.812.307, lot: 8814473, manufacturing site: (b)(4).Release to warehouse date: apr.04, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the surgeon used the trial with the applicator.While trying to remove the trial implant from the disk space the trial detached from the applicator.The surgery was completed successfully with 5 minutes delay.There were no patient consequences are reported.This complaint involves two (2) devices.This report is for (1) t-pal trial spacer 10mm x 28mm 7mm height.This report is 1 of 3 (b)(4).

• Brand Name: T-PAL TRIAL SPACER 10MM X 28MM 7MM HEIGHT
• Type of Device: TEMPLATE
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11748830
• MDR Text Key: 249748007
• Report Number: 8030965-2021-03443
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 07611819418974
• UDI-Public: 07611819418974
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.307
• Device Lot Number: 8814473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1