MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VERTECEM V+ SYRINGE KIT; CEMENT DISPENSER

Model Number	03.702.215S
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, 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 (b)(6) 2020 during a vertebroplasty procedure, when the surgical cement was loaded into the 1cc syringes it propelled from the plunger.This prevented loading the cement for injection.There was a surgical delay of five (5) minutes.The procedure was successfully completed with the use of alternative 2cc syringes.There was no patient consequence.Concomitant device reported: unknown cement (part#: unknown, lot#: unknown, quantity: 1) this report is for one (1) vertecem v+ syringe kit.This is report 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.Part 03.702.215s, lot 8022529: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: march 13, 2018.Expiry date: february 01, 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, it is observed that one blue connector and thirteen 1ml syringes were received (5 white, 8 blue).One of the blue syringe plungers was stuck due to hardened cement.One of the blue syringe plungers was disconnected from body.No defect was observed with the rest of the syringes received.Functional test was be performed for the syringes with the hardened cement.Rest of the syringes received were working normally as intended.But the reported leak condition cannot be confirmed.The relevant drawings were reviewed; no design issues or discrepancies were noticed.The complaint condition was not confirmed.There were no issues during the manufacture of this product that would contribute to this complaint condition.A definitive root cause cannot be determined for the reported problem.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.
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.H3, h6: the device has been 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.

• Brand Name: VERTECEM V+ SYRINGE KIT
• Common Device Name: CEMENT DISPENSER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10771382
• Report Number: 2939274-2020-04926
• Device Sequence Number: 2113383
• Product Code: KIH
• UDI-Device Identifier: 10705034721699
• UDI-Public: (01)10705034721699
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2020

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: 02/01/2023
• Device Model Number: 03.702.215S
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 8022529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 12/08/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CEMENT