MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REPLACEMENT ALIGNMENT INDICATOR FOR 357.372; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number N55

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Pma/510k: unknown.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary - the investigation could not be completed; no conclusion could be drawn.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

It was reported on an unknown date, during regular cleaning of the tfn helical blade insertion handle it was noticed that the n55 was unable to be taken off from the handle and therefore the insertion handle/helical blade inserter was not able to disassemble properly.There was no patient involvement.Concomitant device reported: unknown tfn helical blade (part # unknown, lot # unknown, quantity 1).This complaint involves two (2) devices.This report is for one (1) replacement alignment indicator for 357.372.This report is for 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: REPLACEMENT ALIGNMENT INDICATOR FOR 357.372
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8729071
• MDR Text Key: 149086198
• Report Number: 2939274-2019-58826
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982002143
• UDI-Public: (01)10886982002143
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: N55
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1