MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 3.5MM AGGRESSIVE PLUS 5PK; ATHROSCOPIC SHAVER SYSTEM BLADE

Model Number	283319
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Udi: (b)(4).The expiration date is unknown.
Event or Problem Description
It was reported by the affiliate via complaint submission tool that during a knee arthroscopy with meniscal repair the 3.5 mm aggressive plus 5pk did not suction, blade was full.Procedure was completed, however a surgical delayed of 5 minutes was reported.No patient consequence was reported.No additional information provided.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summary = > the device was received for evaluation.Visual inspection confirms that the proximal end of the inner blade was clogged with a foreign matter that appeared to be the same plastic material that the hub was made from.The complaint device was reviewed with the plastic molding engineer that is responsible for the product.This would not allow fluid to flow through the device and create the suction issue.This issue has been escalated to a capa.This complaint can be confirmed.A manufacturing record evaluation was performed for the finished device lot and product number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy 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.Device history lot = > a manufacturing record evaluation was performed for the finished device lot and product number, and no non-conformances were identified.

• Brand Name: 3.5MM AGGRESSIVE 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: 9136699
• Report Number: 1221934-2019-58688
• Device Sequence Number: 16940358
• Product Code: HRX
• UDI-Device Identifier: 10886705027231
• UDI-Public: 10886705027231
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K131191
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2019

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 Model Number: 283319
• Device Catalogue Number: 283319
• Device Lot Number: A1811011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 02/07/2020
• Patient Sequence Number: 1