MAUDE Adverse Event Report: DEPUY MITEK LLC US FULL RADIUS 5.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number	283709
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4)-incomplete.The exp date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during rotator cuff repair surgical procedure, it was observed that the full radius 5.0mm 5pk device had abrasion.It was reported that the device was removed.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.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).If information is obtained that was not available for the initial medwatch.A follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.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 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
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.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 records reviewed.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 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 event information received on 12/03/2018.It was reported by an affiliate that there are no devices comes back.
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 additional information should become available, a supplemental medwatch will be submitted accordingly.Correction: initial report: the initial report was documented incorrectly on the initial report.The reporter's name and address have been updated to reflect the correct information.Additional information: event description: subsequent follow-up with the customer, additional information was received.It was reported that there was a second device that had metal abrasion.Therefore, this is report 1 of 2 for the same event.The updated event is as follows: this is report 1 of 2 for the same event.It was reported by the affiliate in switzerland that during rotator cuff repair surgical procedure, it was observed that two full radius 5.0mm 5pk devices had metal abrasion.It was reported that the device was removed.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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.Corrected data: date received by manufacturer on follow-up 2 should be december 6, 2018.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.

• Brand Name: FULL RADIUS 5.0MM 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7947439
• Report Number: 1221934-2018-54883
• Device Sequence Number: 16376260
• Product Code: HRX
• UDI-Device Identifier: 10886705022069
• UDI-Public: 10886705022069
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K041824
• 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,Followup
• Report Date (Section B): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 283709
• Device Lot Number: M1607011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/03/2018; 11/03/2018; 12/03/2018; 10/21/2019
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/02/2018; 12/05/2018; 12/06/2018; 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention