MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO RASP 20 DOWNBEND *EA; BONE RASP

Catalog Number	214620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Depuy synthes mitek received and evaluated the complaint device.Visual inspection of the device revealed the device was broken in two pieces.The metal shaft was broken off at the shaft/handle interface, confirming this complaint.The root cause of this failure is excessive shear force exerted on the metal shaft.This failure may be attributed to device mishandling.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.At this 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 to monitor the extent to which this complaint is observed in the field.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a shoulder arthroscopy stabilization surgical procedure, it was observed that the arthro rasp 20 downbend ea device broke between the metal shaft and the handle.According to the reporter, the event occurred while the surgeon was rasping the glenoid.It was not reported if there was delay in the surgical procedure or if a spare device was used to complete the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Correction: upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
(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.Corrected data: (g4) - date received by manufacturer.
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: udi: (b)(4).Correction: b1, h1: it was inadvertently reported on the previous report that the reported malfunction was unlikely to cause or contribute to serious injury or death if it were to recur.However, upon further review, it was determined that this complaint is reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: depuy synthes mitek received and evaluated the complaint device.Visual inspection of the device revealed the device was broken in two pieces.The metal shaft was broken off at the shaft/handle interface, confirming this complaint.The root cause of this failure is excessive shear force exerted on the metal shaft.This failure may be attributed to device mishandling.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.At this time, no corrective action is required and no further action is warranted.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Device history lot: dhr review determined that there were no anomalies or discrepancies in the manufacture of the lot: this report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

• Common Device Name: BONE RASP
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8266560
• Report Number: 1221934-2019-56078
• Device Sequence Number: 16736878
• Product Code: NBH
• UDI-Device Identifier: 10886705004034
• UDI-Public: 10886705004034
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 11/21/2016

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 Catalogue Number: 214620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Initial Date Received by Manufacturer: 11/21/2016
• Supplement Date Received by Manufacturer: 11/21/2016; 11/21/2016; 01/25/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/07/2019; 09/25/2019; 10/19/2019
• Patient Sequence Number: 1