MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - REAMERS: REAMER HEAD

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: only event year is known.510k: this report is for an unknown reamers: reamer head: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Investigation summary: the complaint device was not received for investigation.An investigation was performed based on the image.The image was reviewed, and the complaint condition can be confirmed.There are fragments of the reamer head visible in the radiograph.The experience code of "unable to assemble" cannot be confirmed as the part was not returned and a functional test cannot be performed.Due to the trend of broken ria 2 reamer heads identified during post market surveillance, capa was raised to determine the root cause of the breakages.The root cause was identified as a deviation from the recommended surgical approach of 10 degrees.Additionally, the product issue escalation was initiated to define any further action related to the breakage.Capa applies to all reamer head part numbers in the ria 2 system, and the complaint part is a reamer head in that system.Therefore, even though there is no definitive product code for this part, it can be determined that the capa is applicable.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.There was no lot number provided, therefore a manufacturing record evaluation cannot be performed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed 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 an unknown date, while reaming for a piriformis nail using the ria 2 the malunion, initially reamed with an 8.5 with the flexible reamers.The ria failed before reaching the level of the lesser trochanter, fragments were generated.Procedure was completed successfully without any surgical delay.This report involves one (1) unknown reamers: reamer head: trauma.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNK - REAMERS: REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12632476
• MDR Text Key: 276399080
• Report Number: 2939274-2021-06111
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DRIVE SHAFT FOR RIA 2 520MM; UNK - NAILS; UNK - REAMING RODS