MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 2.7MM MINI ULTRA-AGGR PLUS 5PK; ATHROSCOPIC SHAVER SYSTEM BLADE

Model Number	283229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Additional narrative: udi: (b)(4) incomplete.The lot number is unknown.
Event or Problem Description
It was reported by sales representative via complaint submission tool that during an elbow scope and utilizing the mitek 2.7mm mini ultra-aggressive blade plus(2.7mm mini ultra-aggr plus 5pk) for his shaver.During its use, we noticed the blade was not spinning inside of the shaver sheath.Upon removing it from the joint, we disassembled the shaver and found the blade inside to be broken in half.The item was discarded and another opened.There was a surgical delay of 2 minutes.No patient harm occurred and all broken pieces were recovered.The device is available to be returned for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (a1811008), and no non-conformance was identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
Additional Manufacturer Narrative
H10 additional narrative: additional information: d4, h10: the lot number and expiration date have been updated accordingly to reflect the correct information.Therefore, udi: (b)(4).

• Brand Name: 2.7MM MINI ULTRA-AGGR PLUS 5PK
• Common Device Name: ATHROSCOPIC SHAVER SYSTEM BLADE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10143548
• Report Number: 1221934-2020-01533
• Device Sequence Number: 19658268
• Product Code: HRX
• UDI-Device Identifier: 10886705027194
• UDI-Public: 10886705027194
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 283229
• Device Catalogue Number: 283229
• Device Lot Number: A1811008
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/21/2020; 09/10/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/22/2020; 09/10/2020
• Patient Sequence Number: 1