MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE PEEK 3SUT W/OC; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222304
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair the inserter shaft of the healix advance peek suture anchor broke during insertion.The surgeon was not able to locate and retrieve the fragments of the shaft.The rep was not present during the case and he is not aware on any additional intervention at this time.The procedure was completed with the same anchor.The device will return for evaluation.
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: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported by the sales rep that he would imagine that there was a couple minute delay as the surgeon attempted to remove the portion of inserter shaft that broke off inside the anchor.It was reported that there were no patient consequences or impact to the user or patient, other than the portion of the inserter shaft that remained in the anchor.It was reported that it was the sales rep understanding that it was not a loose fragment, but embedded in the anchor that is implanted in the shoulder.It was reported that the sales rep had no knowledge if there was additional intervention provided to locate the fragment search of the surgical site, x-ray, floroscopy.It was reported that the sales rep had no knowledge if the surgeon was concerned with a retained fragment.It was reported that the sales rep had no knowledge if there were any antibiotics or prophalactic treatment provided to the patient.It was reported by the sales rep that the repair was completed successfully.
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.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.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
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: additional information: investigation summary = > according to the information provided, it was reported that during a rotator cuff repair the inserter shaft of the healix advance peek suture anchor broke during insertion the complaint device was received and evaluated.Visual observations confirm that are missing components as the 4.5mm healix advance peek anchor, handle, driver, suture card, suture gripper, triple barrel, cover, handle.Also was observed that the shaft is broken.Confirming this complaint.The possible root cause for the reported failure can be attributed to anchor breakages are associated with off -axis insertion, levering during insertion or hard bone quality, however; this cannot be conclusive determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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 HEALIX ADVANCE PEEK 3SUT W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9667943
• Report Number: 1221934-2020-00477
• Device Sequence Number: 3414570
• Product Code: HWC
• UDI-Device Identifier: 10886705021406
• UDI-Public: 10886705021406
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/28/2020

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 Expiration Date: 06/30/2022
• Device Model Number: 222304
• Device Catalogue Number: 222304
• Device Lot Number: 5L45370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 02/29/2020; 03/03/2020; 03/15/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/03/2020; 03/04/2020; 03/16/2020
• Patient Sequence Number: 1