MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RETRACTOR BODY

Model Number	03.816.001
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.A review of the device history record has been requested.Device history lot, part: 03.816.001, lot: l881095, manufacturing site: (b)(4) release to warehouse date: 29 nov 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.It was reported on june 25, 2019, during an inspection of the loaner set, a retractor body and a 3rd blade holder were not functioning correctly.The 3rd blade holder was discovered not allowing the blade to be inserted flush.The issue was discovered during an overview before checking the set in sterile processing department (spd).There was no patient and procedure involvement.This complaint involves two (2) devices.Investigation flow: functional/ device interaction.Visual inspection: retractor body was received at cq.Upon visual inspection at cq, it is observed that the surface of the device does not show any damage that would contribute to the complaint condition.One of the carbon handles are loose and moving freely, but the screw holding this handle was still tight enough.But, this would not contribute to the reported condition.Functional test: functional test was performed at cq.The third blade holder (03.816.004) was tried to be inserted into retractor body and it was sliding properly into retractor body.Thus, the reported device interaction condition cannot be confirmed.But, the reported device interaction condition cannot be confirmed.Dimensional inspection: dimensional inspection is not required as the complaint cannot be confirmed during functional testing.Document/ specification review: the following drawing(s) was reviewed; retractor (part.No: 03.816.001): se_429809 rev.H, carbon handle cpl, lateral retractor: se_429158 rev.C, central arm cpl, lateral retractor (part.No: 03.816.004): se_429008 rev.E.No design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, functional testing, and document specification review of the received device was performed at cq.A definitive root cause could not be determined, it is possible due to mishandling of the device.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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.
Event or Problem Description
It was reported on june 25, 2019, during an inspection of the loaner set, a retractor body and a 3rd blade holder were not functioning correctly.The 3rd blade holder was discovered not allowing the blade to be inserted flush.The issue was discovered during an overview before checking the set in  sterile processing department (spd).There was no patient and procedure involvement.  this complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

• Brand Name: RETRACTOR BODY
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8805387
• Report Number: 2939274-2019-59268
• Device Sequence Number: 16223354
• Product Code: GAD
• UDI-Device Identifier: 10705034730622
• UDI-Public: (01)10705034730622
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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 Model Number: 03.816.001
• Device Catalogue Number: 03.816.001
• Device Lot Number: L881095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1