MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ACCESS KIT 10 GAUGE-DIAMOND TIP/SIDE-OPENING-STERILE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 03.804.519S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Patient height reported as 1.55m.Patient identifier is unknown.Additional procodes: lxh, kih, mjg.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number and email address are unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.(b)(4).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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, balloon kyphoplasty was performed.The surgeon placed the access kit and wanted to perform the balloon through the trocar.This was not possible because the balloon did not go through the lumen of the trocar.Surgeon used a different access kit in the vertebral bodies, and this balloon showed an irregular shape.The surgeon stated that he has never before observed this with synflate devices.The lumen is different in both kits.One of the inner trocars does not fit into the outer trocar; therefore, the balloons could not be placed through the outer trocar.Intraoperatively, it turned out that vertebral bodies were osteoporotic.Needles could be introduced into the bone without hammering.Surgery was completed successfully, with a twenty (20) minute delay.Patient outcome is okay.This report is for a access kit 10 gauge-diamond tip/side-opening-sterile.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental 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.

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.Device history record (dhr) review: part: 03.804.519s; lot: 16h17-1; manufacturing site: selzach; supplier: sfm medical devices gmbh; release to warehouse date: 26.Aug.2016; expiry date: 01.July 2021.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary: investigation selection, investigation site: cq zuchwil, selected flow: 2.Device interaction/functional.Visual inspection: the visual inspection of the access kit has shown no abnormal findings on these returned parts.All in all the parts are in used condition.Based on this result, we can exclude a manufacturing fault.Function test: no abnormal findings were identified on these returned parts.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Summary: the received condition of these parts are nonconcordant with the complaint description and the complaint condition is unconfirmed.No abnormal findings were identified on these returned parts.All in all the parts are in used condition.Based on that and the condition of the parts a product related issue can be excluded.Unfortunately we are not able to determine the exact cause which leads to this occurrence.We can only assume that during use the synflate l balloon, has caused the occurrence (b)(4).Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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 10 GAUGE-DIAMOND TIP/SIDE-OPENING-STERILE
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7598456
• MDR Text Key: 111025315
• Report Number: 8030965-2018-54324
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 07611819540569
• UDI-Public: (01)07611819540569
• 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,Followup
• Report Date: 05/22/2018

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: 07/01/2021
• Device Catalogue Number: 03.804.519S
• Device Lot Number: 16H17-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/21/2018; 09/07/2018
• Supplement Dates FDA Received: 07/19/2018; 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 56