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

Catalog Number	03.702.215S
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
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is synthes sales consultant.A review of the device history records has been requested.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, the tip (¿nose¿) of the syringes broke off.It is unknown if there were patient and procedure involvement.This report is for one (1) vertecem v+ syringe kit.This is report 2 of 2 for complaint (b)(4).
Event or Problem Description
It was reported that on an unknown date during an unknown procedure, the tip (¿nose¿) of the syringes broke off.It is unknown if there was a surgical delay.
Additional Manufacturer Narrative
Device history lot part: 03.702.215s, lot: 8052501, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 12.June 2018, expiry date: 01.May 2023.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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: 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: 7962605
• Report Number: 8030965-2018-57294
• Device Sequence Number: 1572457
• Product Code: OAR
• UDI-Device Identifier: 07611819396074
• UDI-Public: (01)07611819396074
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/27/2018

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: 05/01/2023
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 8052501
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1