MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIXADVPEEK3SUTANC PCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	223135
Medical Device Problem Codes	Crack (1135); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
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.Udi: (b)(4) - incomplete.The expiration date is not currently available.
Event or Problem Description
Patient was brought back for a revision rotator cuff repair.When examining the retear, we noticed that the first anchor had pulled out and cracked along the side of the anchor.Patient consequence? unknown.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.The expiration date was reported as unknown in the initial report and has been updated as 5/31/2020; therefore, udi: (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, however photos of the actual device were received and examined.This complaint was confirmed.  a non-conformance search was performed for this product code 223135-lot #l436568 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.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.

• Brand Name: 4.5 HEALIXADVPEEK3SUTANC PCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7544354
• Report Number: 1221934-2018-50853
• Device Sequence Number: 11082022
• Product Code: MAI
• UDI-Device Identifier: 10886705024759
• UDI-Public: 10886705024759
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K133794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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: 05/31/2020
• Device Catalogue Number: 223135
• Device Lot Number: L436568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR