MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.75 HEALIX ADVANCE KNTLSS BR; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222330
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: udi: (b)(4).The lot number is not currently available.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 cst tool that during a rotator cuff repair procedure two of the customer's 4.75 healix advance knotless br anchors and one of 5.5 healix advance knotless br anchor that did not work.The procedure was completed with no surgical delay or patent consequences.There was no fragments generated.Further it was reported by the sales rep that the anchors would not advance.The sales rep stated that the patient had very bad bone quality.The procedure was completed using the same bone hole with a competitor's device.The sales rep could not provide lot numbers for the devices as they were discarded by the customer.
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.The sales rep stated that the patient had very bad bone quality, it might have caused difficulty for the anchor to advance, therefore is a possible root cause of the reported issue.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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).The lot number is unknown.

• Brand Name: 4.75 HEALIX ADVANCE KNTLSS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8936315
• Report Number: 1221934-2019-58116
• Device Sequence Number: 18986935
• Product Code: MAI
• UDI-Device Identifier: 10886705030316
• UDI-Public: 10886705030316
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K171114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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 Catalogue Number: 222330
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/22/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/23/2019
• Patient Sequence Number: 1