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

Catalog Number 03.702.215S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2019, during an unknown procedure, two (2) vertecem syringe kits were bent and broken after removing from the vertecem cement kit reservoir.It was not possible anymore to attach the syringes to the standard luer needle since the tip of the syringe screw got bent and broke.The procedure was successfully completed by using other syringes that were still good.No surgical delay and no patient consequence reported.Concomitant device reported: unknown vertecem cement kit (part # 07.702.016s, lot# unknown, quantity 1).This report is for one (1) vertecem v+ syringe kit.This is report 2 of 2 for (b)(4).

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.Additional narrative: device history lot.Part: 03.702.215s.Lot:8102588.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 16 dec 2018.Expiry date: 01.Oct 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary picture review does not allow for a conclusive statement concerning complaint condition.Three syringes out of the two mentioned vertecem v+ syringe kits were returned by customer and forwarded to the manufacturer (symatese device), where they were checked for conformance to the specifications.Abstract from supplier's report: 3 samples of 1ml syringes have been returned for investigation.Visual inspection showed that the luer tip of the sample 1 is broken, the two other ones are damaged.The luer threads at the bottom of the 3 samples are damaged which could be an indication that the screwing has been forced.This production lot (8102588) was manufactured in december 2018 according to the specification with no non-conformities reported no anomaly or deviation in relation with the complaint, was reported during the manufacturing of this production lot.According to the performed investigation and the samples analysis, the potential cause identified is due to the combination of two events: screwing 'too hard' to the bottom of threads internal diameter of the stopcock luer at the minimal dimension - but still within tolerance the design of the syringe can't limit screwing torque.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
• Type of Device: CEMENT DISPENSER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8381868
• MDR Text Key: 137541557
• Report Number: 8030965-2019-61627
• Device Sequence Number: 1
• Product Code: OAR
• UDI-Device Identifier: 07611819396074
• UDI-Public: (01)07611819396074
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

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 Expiration Date: 10/01/2023
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 8102588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1