MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL TRIAL SPACER 12MM X 32MM 15MM HEIGHT; TEMPLATE

Catalog Number	03.812.515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 the product broke.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
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 h3, h6: part: 03.812.515.Lot: 9826430.Manufacturing site: hägendorf.Release to warehouse date: 09.Mar.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.
Event or Problem Description
The issue was discovered during decontamination at the sterilization department.

• Brand Name: T-PAL TRIAL SPACER 12MM X 32MM 15MM HEIGHT
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9862450
• Report Number: 8030965-2020-02159
• Device Sequence Number: 3432152
• Product Code: HWT
• UDI-Device Identifier: 07611819420762
• UDI-Public: (01)07611819420762
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 03.812.515
• Device Lot Number: 9826430
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1