MAUDE Adverse Event Report: SYNTHES GMBH ACCESS KIT-STERILE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	03.804.612S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on 22-february-2024 a percutaneous vertebroplasty was performed.During the procedure, the surgeon noted that the connection between the working sleeve and the trocar/cement needle of the access kit in question was less than usual.The procedure was completed successfully with no surgical delay.The patient status is stable.No additional medical intervention was required.No further information is available.This report is for an access kit-sterile.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: 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.
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.Corrected data: d9.G1.Additional narrative: e1 h3, h4, h6: part: 03.804.612s.Lot: 23g28-1.Manufacturing site: werk selzach logistik.Supplier: (b)(4).Release to warehouse date: 28 july 2023.Expiration date: 28 july 2028.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Only the working sleeves, the trocars diamond tip and the cement needle were returned for evaluation.Visual analysis of the returned sample revealed that there was no damage or defects with the access kit 4.7.A functional test was performed, the working sleeve was able to assure the trocar diamond tip with out problems.The devices works as intended and were able to assembled and disassembled, therefore the reported allegation was not able to be replicated.The synflate® vertebral balloon surgical technique guide was reviewed.Following relevant statements were found.Warnings: ¿ensure that the trocar instrumentation does not breach the anterior wall of the vertebral body.¿only hammer on the blue plastic handles of the access instrumentation.Confirm proper positioning of the access instrumentation under fluoroscopy in both ap and lateral view.¿do not insert or advance the working sleeve in the bone without the trocar.This could damage the working sleeve and obstruct balloon insertion.¿do not redirect the instrument assembly without removing it and re-accessing the vertebral body.The overall complaint was not confirmed as the access kit 4.7 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed.-working cannula (current & manufactured).-working cannula and cannulated trocar (current & manufactured).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: ACCESS KIT-STERILE
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18878158
• Report Number: 8030965-2024-03492
• Device Sequence Number: 12734180
• Product Code: GEA
• UDI-Device Identifier: 10705034810881
• UDI-Public: (01)10705034810881
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Catalogue Number: 03.804.612S
• Device Lot Number: 23G28-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown