MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA; REAMER

Model Number 314.743

Device Problem Material Integrity Problem (2978)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: initial reporter is a j&j employee.A device history record (dhr) review was conducted: visual inspection: the drive sft-minimum 520 lnth-for use ria (part# 314.743, lot# h854513 qty# 1) was returned and received at us cq.Upon visual inspection, it is observed that the distal tip of the driveshaft was broken.The broken tip fragment was not returned.No other issues were found with the device.Dimensional inspection: dimensional inspection was performed for the design of device.Document/specification review: the following drawings (current and manufactured to) were reviewed.No design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for the drive sft-minimum 520 lnth-for use ria (part# 314.743, lot# h854513 qty# 1).A definitive root cause could not be identified for the reported issue from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part #: 314.743, synthes lot #: h854513, supplier lot #: h854513, release to warehouse date: 5 nov 2019, suppliers: (b)(4).No ncr's generated during production.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.

Event Description

It was reported that on (b)(6) 2021, the ria reamer tip was damaged.No patient or hospital involvement.This report is for one (1) drive sft-minimum 520 lnth-for use ria.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA
• Type of Device: REAMER
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13581128
• MDR Text Key: 286767428
• Report Number: 2939274-2022-00604
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.743
• Device Catalogue Number: 314.743
• Device Lot Number: H854513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1