MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH T-PAL TRIAL SPACER 10MM X 28MM 8MM HEIGHT; TEMPLATE

Catalog Number	03.812.308
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Initial reporter is synthes affiliate subject device has been received and is currently in the evaluation process.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 europe reports an event in (b)(4) as follows: it was reported, that on (b)(6) 2017, the surgery for degenerative scoliosis was performed by using transforaminal posterior atraumatic lumbar (t-pal) cage system.The fixed area was l2 ¿ sai.After the surgeon determined the size of the t-pal trial implant by fitting, the surgeon the trial spacer momentarily by the slide hammer.When the nurse was detaching the t-pal trial spacer from the handle of the slide hammer, it was found that the t-pal trial spacer was detached from the handle before returning the determined position.When looked at very carefully, it was noticed that the tip of the round protrusion part was broken.The side button on the knob of the holder could not be pressed down.The surgery was completed successfully with no delay, and there was no adverse consequence to the patient.Concomitant devices reported: t-pal trial implant (part number unknown, lot number unknown, quantity 1), slide hammer (part number unknown, lot number unknown, quantity 1) this report is for one (1) t-pal trial spacer this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part 03.812.308, lot 8311366: release to warehouse date: december 05, 2013.Manufacturing site: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: the knob at the end of the shaft of instrument is broken off.During manufacturing investigation, the hardness and the undercut diameter close to breakage were measured; both results are within specification and are in accordance to product drawing.No production fault has been found.The knob on the coupling end of instrument is broken off due to mechanical overload during surgery.No manufacturing related issue was identified and/or confirmed.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 TRIAL SPACER 10MM X 28MM 8MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7190591
• Report Number: 8030965-2018-50354
• Device Sequence Number: 1065887
• Product Code: HWT
• UDI-Device Identifier: 07611819418981
• UDI-Public: (01)07611819418981(10)8311366
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2017

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: 03.812.308
• Device Lot Number: 8311366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/15/2018
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1