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

Catalog Number	03.612.001
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) was setting up for an anterior procedure and posterior procedure.Where we found that the synframe for half ring x2 were missing screws as well as the proaccess vertical mast was not properly holding the mis flexarm despite retightening the post on this instrument.The doctor managed to make the instruments work for his procedures, however these instruments would need to be replaced.The patient was not impacted.No other information is available for reporting.Concomitant device reported: unknown proaccess mis flexarm (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: 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: 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: 9649286
• Report Number: 2939274-2020-00571
• Device Sequence Number: 11460855
• Product Code: GAD
• UDI-Device Identifier: 07611819782457
• UDI-Public: (01)07611819782457
• 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
• Report Date (Section B): 01/09/2020

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 Catalogue Number: 03.612.001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/17/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PROACCESS MIS FLEXARM