MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5HLX ADV PK ANC-DYNA 3-SUT; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222033

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091); No Code Available (3191)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 Description

It was reported by the customer via phone that on (b)(6) 2019, the patient underwent a right rotator cuff repair procedure where a 5.5 healix advance peek anchor with dynacord and a 4.5 healix advance peek anchor with dynacord were implanted into the patient's bone.On (b)(6) 2019, the patient noticed increased swelling at the surgical site, but did not experience a fever.On that date, the patient had 5cc of cloudy fluid aspirated from their shoulder and was diagnosed with a p.Acnes infection.On (b)(6) 2019, a revision surgery was performed to remove the two healix anchors from the patient's shoulder.The customer stated that one competitor's implant remains in the patient's shoulder.Additional information received from the affiliate reported the revision surgery was complete by arthroscopic débridement and removal anchors.It was also reported that the patient was prescribed iv antibiotics for 4-6 weeks.The anchors were sent to pathology for testing and discarded so they are not available for evaluation.The affiliate also stated this was a p-acnes infection.99% chance that came from his skin, not the implants.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformances were identified for this part-lot number combination per qlik query executed 06/27/2019.No further information was made available regarding the event.The sterile load information was reviewed to see if there were any other complaints of patient infection for any products sterilized in the same load with the 2 complaint devices.There were 42 different lots of product containing 9760 devices.A review of the complaint files revealed there were no other complaints for patient infection other than the 2 reported complaint devices.Based off the results of the sterile load review, it is unlikely the reported patient infection was caused by the mitek anchors.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: 5.5HLX ADV PK ANC-DYNA 3-SUT
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8741234
• MDR Text Key: 149413533
• Report Number: 1221934-2019-57449
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705029488
• UDI-Public: 10886705029488
• Combination Product (y/n): N
• PMA/PMN Number: K173859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 222033
• Device Lot Number: L973675
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Patient Sequence Number: 1