MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 3.5MM MINI FULL RAD PLUS 5PK; ATHROSCOPIC SHAVER SYSTEM BLADE

Catalog Number	283609
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.
Event or Problem Description
I need to advise of a broken mitek shaver blade that was used in this hospital on friday last.The list was late afternoon, hence only reporting today remnants of neither of the items was retained.After discussion with the surgeon it transpires that he was using them to burr bone so this may have contributed to the problems this complaint is for one of the codes is (b)(4) full radius blade plus lot m1311033 - this broke off at the plastic interface,.
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.Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.If any additional information is obtained, this complaint will be re-opened to capture that information.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).
Event or Problem Description
Additional information received from affiliate on 19june2018: reportedly there was a ten to fifteen (10-15) minute delay while the dwarf was retrieved and the shaver swapped.There was no other patient consequences or impact to the user.The case was completed; the surgeon used a different burr that was readily available.The failure was noted the day after the case was completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 not currently available.Corrected data: initial alert date should have been 4/27/2018, not 4/30/2018.

• Brand Name: 3.5MM MINI FULL RAD PLUS 5PK
• Common Device Name: ATHROSCOPIC SHAVER SYSTEM BLADE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle 2400 ; CH 2400
• MDR Report Key: 7544047
• Report Number: 1221934-2018-50842
• Device Sequence Number: 19116161
• Product Code: HRX
• UDI-Device Identifier: 10886705027255
• UDI-Public: 10886705027255
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2018

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: 10/31/2018
• Device Catalogue Number: 283609
• Device Lot Number: M1311033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 11/26/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 10/25/2018; 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1