MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE INSERTER; MISC ORTHO SURGICAL INSTR

Catalog Number 357.372

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.No patient information is available for reporting.Event date is unknown date in 2017.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

(b)(4) reported a helical blade inserter broke intraoperatively during a broken nail removal procedure on an unknown date.It was noted the surgeon may have used the helical inserter rather than the helical blade extractor.Concomitant device: nail (part# unknown, lot# unknown, qty 1); helical blade (part# unknown, lot# unknown, qty 1).(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.

Event Description

It was further reported the patient was healed and wanted the implants removed.There was no allegation against the devices.

Manufacturer Narrative

Device history records review was conducted.The report indicates that the: device history lot, part # 357.372, synthes lot #: ft00207, supplier lot #: ft00207, release to warehouse date: 08 nov 2016, supplier: (b)(4), no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Complainant part is not expected to be returned for manufacturer review/investigation.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.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: HELICAL BLADE INSERTER
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7132933
• MDR Text Key: 95822517
• Report Number: 2939274-2017-50372
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982196064
• UDI-Public: (01)10886982196064(10)FT00207
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2017

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: 357.372
• Device Lot Number: FT00207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/21/2017; 02/20/2018
• Supplement Dates FDA Received: 12/22/2017; 02/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1