MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CURVED PEDICLE PROBE 2.4MM

Model Number 03.614.013

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device available: device returned.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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

It was reported that on an unknown date, during a routine incoming inspection, it was discovered that the curved pedicle probe was broken.There was no patient involvement.This complaint involves one (1) device.This report is 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.A review of the device history record device history lot part: 03.614.013, lot: l776504, manufacturing site: hägendorf, release to warehouse date: 16 april 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation summary event description: it was reported that on an unknown date, during a routine incoming inspection, it was observed that the curved pedicle probe was broken.There was no patient involvement.This complaint involves one (1) device.Flow: damaged.Visual inspection: upon visual inspection, there was no defect found with the returned device.The returned device is received intact.Hence, the complaint can not be confirmed for the broken condition.Device failure/ defect identified: no.Conclusion: the complaint condition could not be confirmed as no defects which could affect function of the device could be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A root cause could not be identified as no malfunctions were observed during the course of this investigation.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 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.Corrected data: awareness date reported on follow up 1 report as june 04, 2019 but should have been july 15, 2019.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: CURVED PEDICLE PROBE 2.4MM
• Type of Device: PROBE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8750243
• MDR Text Key: 149778897
• Report Number: 2939274-2019-58950
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034714851
• UDI-Public: (01)10705034714851
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.614.013
• Device Catalogue Number: 03.614.013
• Device Lot Number: L776504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 08/06/2019
• Patient Sequence Number: 1