MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER QA+ #2 ETH CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212032
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional 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).Associated medwatch:1221934-2018-55273.
Event or Problem Description
The customer reports that during an unknown procedure, the wire of the anchor frayed and broke during its use.The surgeon used another anchor with the same lot number: the same problem occurred.The surgeon successfully completed the surgery with a third anchor of a new lot additional information received from the affiliate on (b)(6) 2019 stating the name of the surgeon, a surgical delay of ten (10) minutes occurred during the procedure, and patient demographics.The additional information also stated that there has been no impact to the patient outcome or recovery.It was also stated that all fragments of the broken device were removed and the surgery was completed to the preferred treatment.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this product code 212032 lot l746303 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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).Associated medwatch report number: 1221934-2018-55273.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8065761
• Report Number: 1221934-2018-55274
• Device Sequence Number: 1947041
• Product Code: JDR
• UDI-Device Identifier: 10886705001804
• UDI-Public: 10886705001804
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K930893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2018

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: 01/31/2023
• Device Catalogue Number: 212032
• Device Lot Number: L746303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 11/30/2018
• Patient Sequence Number: 1
• Patient Age: 51 YR