MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY SET/MEDIUM- STERILE; ARTHOSCOPE

Catalog Number 09.804.601S

Device Problems Inflation Problem (1310); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

Event Type  malfunction  

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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.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 is not distributed in the united states, but is similar to device marketed in the usa.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 japan reports an event as follows: it was reported that on (b)(6) 2022, during a percutaneous vertebroplasty (th11) for treating a compression fracture due to osteoporosis, the balloon did not inflate normally.When they attempted the balloon inflation again, the balloon happened to slide into the centrum and the stent did not expand normally.Further troubleshooting did not succeed, and the balloon and the stent were finally separated.While medium contrast was collected from the lesion, they decided to leave the balloon in the centrum.The rest of the procedure was completed without surgical delay.No further information is available.This report is for a vertebral body set/medium- sterile.This is report 1 of 1 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.H3, h4, h6 investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that vertebral body set/medium- sterile was received in one piece and unknown substance was present into the balloon.Broken condition was not observed.A dimensional inspection for the vertebral body set/medium- sterile was unable to be performed due to device design.A functional test was unable to be performed due to inflation system was not returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the vertebral body set/medium- sterile would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: yes, conforms dimensional inspection: n/a.Device history synthes description / part no.Vbs set m (09.804.601s) confluent part no.103411 rev.G confluent lot # 82237172 subbasembly lots # 82241105** release lot quantity: (b)(4).Release to warehouse/manufacture date: 05 feb 2022 expiration date: 01 feb 2025 supplier name: (b)(4).There are no ncrs, deviations or reworks associated during the manufacturing.Process controls all process controls were met, all ctqs were found within the specification.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: VERTEBRAL BODY SET/MEDIUM- STERILE
• Type of Device: ARTHOSCOPE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15334776
• MDR Text Key: 301193671
• Report Number: 8030965-2022-06235
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07611819471856
• UDI-Public: (01)07611819471856
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.804.601S
• Device Lot Number: 82241105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male