MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX BR ANCHOR W/OC&ND; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222232
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/14/2019
Type of Reportable Event	Serious Injury
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.Udi: (b)(4).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 an unknown procedure, it was observed that the 5.5 healix br anchor w/oc&nd device snapped in the dense bone when it was placed correctly in the fibula.As per the affiliate the correct surgical technique was used.There was no patient consequence and no surgical delay was reported.There was anodelay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Udi: (b)(4).
Event or Problem Description
Additional information received from the affiliate reported the case was completed by utilizing a tension suture which was applied to the muscle.The affiliate stated an anchor was not used to complete the procedure.It was reported the devices required for the alternative; a small drill bit and a suture, were readily available.Additional information pertaining to harm or surgical intervention was provided.The affiliate also reported this event occurred during an avulsion fracture for left fibula.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary = > the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Our affiliate mentioned that the anchor was snapped due to dense bone, therefore is a possible root cause of the reported problem.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device lot number (2l06325), and no non-conformances were identified.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.Udi: (b)(4).

• Brand Name: 5.5 HEALIX BR ANCHOR W/OC&ND
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9364544
• Report Number: 1221934-2019-59733
• Device Sequence Number: 19355395
• Product Code: MAI
• UDI-Device Identifier: 10886705007783
• UDI-Public: 10886705007783
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2019

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: 09/30/2021
• Device Model Number: 222232
• Device Catalogue Number: 222232
• Device Lot Number: 2L06325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 01/22/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/06/2019; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1