MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS RC #2 PAN *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	212739
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The lot number was unknown.Investigation summary: the complaint device is not being returned; the availability of the device is unknown, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.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.
Event or Problem Description
This file is a review of the following journal article: jiménez-martín, a., et al (2013) slap lesions: clinical experience of 63 cases.Sa orthopaedic journal, vol.12, pages 32-37 (spain).The study emphasizes on the review of the superior labrum anterior and posterior injuries or slap injuries and to value clinical and working final results after its treatment.The patients evaluated on course of this study: 63 patients.The article describes the following procedure: shoulder repair the devices involved were: unknown bioknotless anchor complications described: we observed that implants moved in 15.2% of cases.Seven cases required a second operation.

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11553307
• Report Number: 1221934-2021-00924
• Device Sequence Number: 17155737
• Product Code: MAI
• UDI-Device Identifier: 10886705002245
• UDI-Public: 10886705002245
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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 Model Number: 212739
• Device Catalogue Number: 212739
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention