MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE; REAMER

Model Number	351.706S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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 or Problem Description
It was reported that on (b)(6) 2021, the reaming rod snapped half of the reamer and was able to remove it.In the second part of the incident, putting the reaming rod down, cutting the front reamer head which ended up shattering inside the patient.Surgeon was not able to retrieve the pieces of the shattered reamer and had to split the fracture further to pull the reaming rod out.Surgery was completed successfully with 60 minutes delay.Concomitant device reported: unk - reamer: (part # unknown; lot # unknown; quantity: 1).This report is for one (1) 2.5mm reaming rod with ball tip/950mm-sterile.This is report 2 of 2 for complaint (b)(4).

• Brand Name: 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11749925
• Report Number: 2939274-2021-02153
• Device Sequence Number: 19890158
• Product Code: HTO
• UDI-Device Identifier: 10886982193858
• UDI-Public: (01)10886982193858
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K042899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 351.706S
• Device Catalogue Number: 351.706S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention