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

Model Number 03.612.001

Device Problem Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

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.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a complex case the proaccess mast was no longer supporting the post for the mira and the synframe rings were missing two screws.The procedure was completed with other sets.The patient was not impacted.This report involves one (1) proaccess(tm) vertical mast.This is report 1 of 2 for (b)(4).

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.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned for investigation.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.

• Brand Name: PROACCESS(TM) VERTICAL MAST
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11483928
• MDR Text Key: 243647317
• Report Number: 2939274-2021-01308
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034714462
• UDI-Public: (01)10705034714462
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.612.001
• Device Catalogue Number: 03.612.001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROACCESS(TM) VERTICAL MAST; SYNFRAME HOLDING RING Ø300 2PART CPL