MAUDE Adverse Event Report: SYNTHES GMBH FEELER F/SCR-CHANNEL STRAIG; PROBE

Catalog Number 388.545

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during a pediatric scoliosis procedure, two (2) spinal instruments were reported as broken during surgery.An expedium verse curved pedicle thoracic probe was bent while being pushed against the bone and now unusable and a feeler for screw channel straight was broken into two pieces.Fragments were generated from the feeler but were easily removed.Another stock of the same devices was used to complete the surgery.The procedure was successfully completed without surgical delay and patient outcome is unknown.This report is for one (1) straight ball tip probe.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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.H10 additional narrative: h3, h4, h6: device history records review was completed for part: 388.545, lot: 4109716, supplier lot: p115835.Supplier: (b)(4), release to warehouse date: may 01, 2000.No non conformance repots were generated during production.The material was reviewed and the hardness value was confirmed to meet the specification with no relevant non-conformance noted.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: product investigation was completed.A piece of about 20mm length is broken off and was returned for investigation.The first 20mm above the fracture face are strongly deformed and point into different directions, also the fragment is strongly deformed.In general is the device in a very used condition, there are wear marks all over the shaft, the markings are faded and the complete surface is slightly discolored from many high temperature cycles during reprocessing.The breakage occurred at the conical part of the shaft, therefore dimensions cannot be verified.The performed evaluation of the manufacturing documents did confirm that the hardness was within the specification.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused damage at the device that was made according the relevant drawing.The complaint is confirmed as the tip of the feeler is broken off as complained.The review of the complaint history has shown that this is the first complaint for this article- and lot combination.Based on that, the age and the overall condition a manufacturing related issue can be excluded.The deformation indicates that the tip was exposed to lateral stress, which can lead to a breakage of the thin feeler like in this case.Wear and tear over the 18 years lifetime may also have played a certain role.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: FEELER F/SCR-CHANNEL STRAIG
• Type of Device: PROBE
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• MDR Report Key: 8294237
• MDR Text Key: 135008908
• Report Number: 8030965-2019-60535
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 07611819718531
• UDI-Public: (01)07611819718531
• 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: 01/14/2019

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 Catalogue Number: 388.545
• Device Lot Number: P115835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 03/19/2019; 03/22/2019
• Supplement Dates FDA Received: 03/19/2019; 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1