MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RIA 2 BONE HARVESTING KIT 520MM STERILE; ACCESSORIES, ARTHROSCOPIC

Model Number 03.404.000S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter telephone number: (b)(6).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history: part # 03.404.000s.Synthes lot # 65p4339.Supplier lot # 65p4339.Release to warehouse date: 18 aug 2020.Expiration date: 31 jul 2021.Manufactured by jabil (b)(4).Jbl-nr-0003925 was generated for a deviated kit/label process outlined in the ria 2 kit bom and packaging modification memo jbl-nr-0003925_65p4332.This non-conformance is not relevant to the complaint condition since use as-is was approved.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

It was reported that on (b)(6) 2020, the patient underwent a revision surgery for a removal of a failed competitor's construct and non-union.A ria 2 bone harvesting kit was done to graft the same femur.During the ria, the ria tube assembly clogged up twice which stopped the flow of irrigation and aspiration.It is unknown exactly why the assembly clogged up but a stringy endosteal tissue potentially from the non union site was taken out of the tube assembly.Only a small amount of bone graft was collected and the surgery proceeded.The surgeon ended up doing an illiac crest bone graft to supplement.It is unknown if there was any surgical delay.The procedure outcome is unknown.There was no patient consequence.This is report 1 of 1 for (b)(4).

• Brand Name: RIA 2 BONE HARVESTING KIT 520MM STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10637274
• MDR Text Key: 210105602
• Report Number: 2939274-2020-04534
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982274236
• UDI-Public: (01)10886982274236
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 03.404.000S
• Device Catalogue Number: 03.404.000S
• Device Lot Number: 65P4339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 87