MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER ARTHROSCOPE ACCESSORY

Model Number 375-951-100

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

The device in question was not returned to medline renewal for evaluation. Our investigation included a review of the device history record, and we reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release. The specific cause of the metal shavings could not be determined at this time. Due to the lack of information surrounding the incident, medline renewal does not have enough information to determine the root cause of the failure. The customer confirmed that no adverse patient consequence or medical intervention was required as a result of the incident. However, in an abundance of caution, medline renewal is filing this medwatch report. Device not returned for evaluation.

Event Description

Medline renewal received a report indicating that a reprocessed stryker formula barrel bur left metal shavings in the patient during a shoulder arthroscopy procedure. No adverse patient consequence was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED ARTHROSCOPIC ABRADER
• Type of Device: ARTHROSCOPE ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756 ; 5415164180
• MDR Report Key: 6068233
• MDR Text Key: 58851525
• Report Number: 3032391-2016-00034
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/30/2019
• Device Model Number: 375-951-100
• Device Lot Number: 314897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/31/2016 Patient Sequence Number: 1