MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.0MM REAMER HEAD FOR RIA 2 STERILE; ACCESSORIES, ARTHROSCOPIC

Model Number 03.404.016S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

It was reported that on (b)(6) 2020 the ria 2 was being used in the left femur.While the ria 2 bone harvesting kit sterile was in the distal femur, the reamer head for ria 2 sterile broke off in the patient.This left four (4) metal pieces inside the femur which were all successfully retrieved by the surgeon.The case was delayed by approximately sixty (60) minutes.The procedure was completely successfully.Concomitant devices: ria 2 bone harvesting kit sterile (part # 03.404.000s, lot # 41p0206, quantity# 1), reaming rod with ball tip (part # 351.706s, lot # 28p881, quantity # 1).This report is for one (1) 10.0mm reamer head for ria 2 sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.H3, h4, h6: a device history record (dhr) review was conducted: part #: 03.404.016s, synthes lot number: 35p0862, supplier lot number: 35p0862, release to warehouse date: 19-dec-2019, expiration date: 31-dec-2029.Supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: 10.0MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10088120
• MDR Text Key: 192024011
• Report Number: 2939274-2020-02503
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886982273932
• UDI-Public: 10886982273932
• Combination Product (y/n): N
• PMA/PMN Number: K111437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.016S
• Device Catalogue Number: 03.404.016S
• Device Lot Number: 35P0862
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/05/2020
• Patient Sequence Number: 1
• Treatment: 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE; 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR