MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LATERAL QUICK INSERTER/DISTRACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.809.921
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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.
Event or Problem Description
It was reported that during a lateral l3-l5 interbody spinal fusion procedure with the mtf allograft oracle spacer on (b)(6) 2020, a lateral quick inserter/distractor became jammed and did not move after successfully placing the first spacer on an unknown level.The surgeon reported that something was frozen as you turn the handle, causing the pusher part to stick.The surgeon used another implant holder for oracle cage for the second level.There was no surgical delay reported.The procedure was completed successfully with no adverse consequence to the patient.Concomitant device reported: unknown oracle spacer (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) lateral quick inserter/distractor.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part: 03.809.921; lot: 3120492; manufacturing site: hägendorf; release to warehouse date: march 30, 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the lateral quick inserter/distractor was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the paddles were bent and the pusher was jammed and will not rotate on its shaft.There were scratches, and the etching on the device has started to fade.No other issues were identified with the returned components of the device.Functional test: the functional test was performed on the returned device.The pusher was not able to rotate clockwise or anticlockwise on its shaft even with added leverage from the pliers due to which the pusher cannot be twisted down through the paddles as intended.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed lateral squid.Investigation conclusion the complaint condition is confirmed for the lateral quick inserter/distractor.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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: LATERAL QUICK INSERTER/DISTRACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9683249
• Report Number: 2939274-2020-00715
• Device Sequence Number: 3135548
• Product Code: LXH
• UDI-Device Identifier: 10705034726700
• UDI-Public: (01)10705034726700
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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 Model Number: 03.809.921
• Device Catalogue Number: 03.809.921
• Device Lot Number: 3120492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CAGE/SPACERS: ORACLE