MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA STANDARD WISHBONE ASSEMBLY; SURGICAL RETRACTOR

Catalog Number	4020
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A customer reported that the wishbone frame of the 4020 standard wishbone assembly was having instability complaint in locking condition.There was no patient involvement and no known surgery delay.
Additional Manufacturer Narrative
The product was not available for evaluation; however a video was provided by the customer.Device history record (dhr) - record not available as no lot or serial number was provided.Review of the video confirms the reported instability.However, root cause cannot be determined, since product has not returned for evaluation and no lot or serial numbers have been provided, which could determine the age and possibly the maintenance history of the device.If product does return, this complaint can be reopened and reevaluated.The reported complaint was confirmed through failure analysis.There were no adverse trends discovered for this issue, and the risk is acceptable, therefore no further investigation or action is required.

• Brand Name: STANDARD WISHBONE ASSEMBLY
• Common Device Name: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10585409
• Report Number: 2125289-2020-00001
• Device Sequence Number: 2831962
• Product Code: GAD
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 4020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1