MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS RC #2 ETHGR *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	212738
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: hty; jdr; mbi.Investigation summary: the complaint device is not being returned, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number (212738), lot number (l320098) combination.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.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.
Event or Problem Description
Device report from synthes (b)(6) reports an event as follows: it was reported that during an arcr surgery the bioknotless ethibond anchor came off from the bone hole when the surgeon implanted into the patient's shoulder.Thus, the surgeon could not implant and fix the anchor.The surgery was finished without any other problem, although it was not reported how the surgery was completed.There were no broken parts in the patient¿s body.It was brand new and the first use when the issue occurred.There was no information of surgical delay and no harm to the patient.No further information was provided by the hospital.This report is for a bioknotless ethibond anchor.This is report 1 of 1 for (b)(4).

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8540443
• Report Number: 1221934-2019-56913
• Device Sequence Number: 19443945
• Product Code: MAI
• UDI-Device Identifier: 10886705002238
• UDI-Public: (01)10886705002238
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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 Expiration Date: 02/29/2020
• Device Model Number: 212738
• Device Catalogue Number: 212738
• Device Lot Number: L320098
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1