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

Catalog Number	690.354.60
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 3 of 3 for (b)(4).
Additional 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.The device has been received, the investigation is in progress, 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.
Additional 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.Investigational summary.The screw rack was received at the us cq.The rack is scratched and discolored.The etching for the measuring guide is offset from where it should start.The latch cover plate has a small, outward dent on its side.No other issues were identified with the returned portions of the device.18 mm screws were measured using the measuring guide on the face plate.The measurements taken via the guide did not match measurements taken by a caliper (ca818).Dimensional inspection: measuring guide increments: 10+/-0.13mm.Measuring guide start to 10mm: 10+/-0.13mm.Measured dimension(s): measuring guide increments: 10.03mm, conforming.Measuring guide start to 10mm: 11.17mm, nonconforming.Device(s) used: ca818.Document/specification was reviewed with no observations.A manufacturing record evaluation was not performed due to an unknown lot #.The complaint is confirmed for the screw rack.The rack is worn and slightly discolored.The etching for the measuring guide on the face plate is offset by approximately 1.17mm.As a result, screw measurements taken via the measurement guide are incorrect.There is no indication that a design issue contributed to the complaint.No definitive root cause could be determined.Based on the investigation findings, pie # (b)(4) was launched.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
• Common Device Name: TRAY, SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8520887
• Report Number: 2939274-2019-57511
• Device Sequence Number: 13933281
• Product Code: FSM
• UDI-Device Identifier: 07611819758230
• UDI-Public: (01)07611819758230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 690.354.60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 06/19/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/12/2019; 06/19/2019
• Patient Sequence Number: 1