MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.5MM REAMER HEAD FOR RIA 2 STERILE

Model Number 03.404.021S

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

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

Event Date 08/16/2020

Event Type  Injury  

Manufacturer Narrative

Additional procode: hrx, part: 03.404.021s, synthes lot: 46p3559, supplier lot: 46p3559, expiration date: january 31, 2030, release to warehouse date: february 27, 2020, 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.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 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 mid shaft femur fracture procedure.During the procedure, while the surgeon was reaming the femoral shaft with a reamer/ irrigator/ aspirator (ria) 2, the tip of the reamer head broke off in the canal.The fragment was extricated except for a few metal shavings that remained in the canal.The procedure was successfully completed with a ten (10) minute surgical delay.Concomitant devices: ria 2 (part: unknown, lot: unknown, quantity: 1).This report is for a 12.5mm reamer head.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, h6: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.Device history lot: part #: 03.404.021s, synthes lot number: 46p3559, supplier lot #: 46p3559, expiration date: jan 31, 2030, release to warehouse date: feb 27, 2020, supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Device history review: 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: 12.5MM REAMER HEAD FOR RIA 2 STERILE
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10536144
• MDR Text Key: 207343734
• Report Number: 2939274-2020-04132
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982274007
• UDI-Public: (01)10886982274007
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.021S
• Device Catalogue Number: 03.404.021S
• Device Lot Number: 46P3559
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Patient Sequence Number: 1
• Treatment: UNK - RIA
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 73