MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW RACK FOR MODULAR FOOT SET; TRAY, SURGICAL INSTRUMENT

Catalog Number 690.354.60

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during an open reduction and internal fixation (orif) of the ankle, while working, the scrub nurse noticed that there was an incorrect measurement of the screw lengths on the screw rack.The nurse decided to open all three of the sets containing this caddy and confirmed that all three were measuring incorrectly.Action taken was measured screw reverses on the measuring guide and confirmed with the paper ruler.The procedure was successful with no surgical delay.Patient outcome is unknown.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).This complaint involves three (3) devices.This report is 2 of 3 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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A product investigation was conducted.Visual inspection: the screw rack was received at the us cq.The rack is scratched, faded, and discolored.There is an identification code ((b)(4) 14) scratched onto the lid and the side of the face plate subcomponent.The nylon coating on the divider shelf subcomponent is peeling in the back of the rack.No other issues were identified with the returned portions of the device.Functional test: 18 mm screws were measured using the measuring guide on the face plate.The measurements taken via the guide appear to match measurements taken by a caliper.The complaint can not be replicated with the returned device.Dimensional inspection: dimensional inspection was performed and found to be confirming as per relevant drawings.Device history: a dhr review was not performed due to an unknown lot number.This complaint is not confirmed.Conclusion: the complaint was not confirmed for the screw rack.The device was worn, faded, slightly discolored, and the divider shelf subcomponent was peeling.The measuring guide on the face plate was accurate to the tolerances stated in the device drawing.There was no indication that a design or manufacturing issue contributed to the complaint.No definitive root cause could be determined.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.

• Brand Name: SCREW RACK FOR MODULAR FOOT SET
• Type of Device: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8520885
• MDR Text Key: 142213358
• Report Number: 2939274-2019-57507
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 07611819758230
• UDI-Public: (01)07611819758230
• 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: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 690.354.60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 06/18/2019
• Patient Sequence Number: 1