MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional pro-codes: hty, jdr; mbi; hwc investigation summary: the complaint device was received and evaluated.Visual observation confirms the distal tip of the anchor is broken, but is held in place by suture.When observed under magnification, no structural anomalies were observed that could have contributed to this failure.Anchor breakages are typically associated with off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole.The possible root cause for the reported failure could be attributed to user mishandling of the device.However, from the given information the definitive root cause cannot be determined.No non conformances were identified for this part number, lot number combination per qlik query executed on 08/05/2019.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 history: lot no non conformances were identified for this part number, lot number combination per qlik query executed on 08/05/2019.Udi #: (b)(4).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
It was reported by the sales rep via phone that during a rotator cuff repair procedure the distal tip of the customer's 5.5mm healix peek anchor with orthocord broke upon insertion.The sales rep stated that the surgeon was off axis.The procedure was completed with another like device using the same bone hole with no patient harm or surgical delay to the casee.The sales rep stated that no debris was left in the patient.The patient's bone quality was average.The device will be returning for evaluation.This report is 1 of 1 for (b)(4).

• Brand Name: 5.5MM HEALIX PEEK ANCHOR W/ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8942652
• Report Number: 1221934-2019-58147
• Device Sequence Number: 2151426
• Product Code: MAI
• UDI-Device Identifier: 10886705007578
• UDI-Public: (01)10886705007578
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2019

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: 11/30/2021
• Device Model Number: 222209
• Device Catalogue Number: 222209
• Device Lot Number: 2L44386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/28/2019
• Patient Sequence Number: 1