MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ SYRINGE KIT; CEMENT DISPENSER

Catalog Number	03.702.215S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a synthes sales representative.Complainant part is not expected to be returned for manufacturer review/investigation.Part 03.702.215s, lot 9112687: manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: january 28, 2020.Expiry date: december 01, 2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 synthes (b)(6) reports an event as follows: it was reported that when syringes of the vertecem syringe kit were filled with vertecem v+ cement, the puncheon backed out of the barrel.The procedure was successfully completed with no delay or consequence to the patient.This report is for a vertecem syringe kit.This is report 1 of 1 for (b)(4).

• Brand Name: VERTECEM V+ SYRINGE KIT
• Common Device Name: CEMENT DISPENSER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9864805
• Report Number: 8030965-2020-02164
• Device Sequence Number: 3881400
• Product Code: KIH
• UDI-Device Identifier: 07611819396074
• UDI-Public: (01)07611819396074
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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 Expiration Date: 12/01/2024
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 9112687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/23/2020
• Patient Sequence Number: 1