MAUDE Adverse Event Report: SYNTHES GMBH VERTECEM V+ SYRINGE KIT; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number	03.702.215S
Medical Device Problem Codes	Break (1069); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Serious Injury
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: device avilable for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter occupation: reporter is a j&j employee.(b)(4).Device evaluated by mfr: 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 on (b)(6) 2022, that this was a percutaneous vertebroplasty (l2) for treating compression fracture due to osteoporosis on (b)(6) 2022.Once they started mixing up cement materials, the handle became immovable.They continued the procedure with replacements.When they attached a syringe to a cement needle, the syringe happened to be connected at a slanted angle.When the syringe was detached for a retrial, the tip broke off.The rest of the procedure was completed less than 30-minute surgical delay.No further information is available.This report is for one (1)vertecem v+ syringe kit this is report 2 of 2 for complaint (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: a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 03.702.215s.Lot no: 1102565.Release to warehouse date: 04 november 2021.Manufacturing site: werk selzach.Supplier: symatese device.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: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15159160
• Report Number: 8030965-2022-05531
• Device Sequence Number: 12303830
• Product Code: OAR
• UDI-Device Identifier: 07611819396074
• UDI-Public: (01)07611819396074
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 1102565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 08/15/2022; 10/05/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/07/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown