MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROACCESS(TM) VERTICAL MAST; RETRACTOR

Model Number	03.612.001
Medical Device Problem Codes	Compatibility Problem (2960); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.The investigation could not be completed, no product was received; 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 on an unknown date, the mis support bar attachment will not tighten properly anymore.Action taken when the event occurred opened the second set of mis support instruments.Item just would not tighten anymore, nothing was broken, no fragments.There was a surgical delay of five minutes.The procedure was successfully completed.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) proaccess(tm) vertical mast.This report is 1 of 1 for (b)(4).
Event or Problem Description
The initial complaint was reviewed and found not reportable.Additional information received indicates that this device had no complaint against it.The complained device was the table clamp and is captured on manufacturer report number 2939274-2020-05447.

• Brand Name: PROACCESS(TM) VERTICAL MAST
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10959784
• Report Number: 2939274-2020-05473
• Device Sequence Number: 2177902
• Product Code: GAD
• UDI-Device Identifier: 10705034714462
• UDI-Public: (01)10705034714462
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 03.612.001
• Device Catalogue Number: 03.612.001
• Device Lot Number: 1428826
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/07/2021
• Patient Sequence Number: 1