MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANT

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.The lot number was unknown; therefore, the expiration date and manufacture date were unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Article information: soshi, u., et al (2021) endoscopic shelf acetabuloplasty concomitant with labral repair, cam osteoplasty, and capsular plication to treat acetabular dysplasia in artistic athletes.The orthopaedic journal of sports medicine, vol.(xx), pages 1 - 10 (japan) the orthopaedic journal of sports medicine, 9(11), 23259671211049222 doi: 10.1177/23259671211049222.Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Attempts were done to obtain more information from the author, however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.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 to which this complaint is observed in the field.Device history lot: given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed, or sterile load review could not be conducted.If the lot number becomes available, the mre review will be performed.

Event Description

This file is a review of the following journal article: soshi, u., et al (2021) endoscopic shelf acetabuloplasty concomitant with labral repair, cam osteoplasty, and capsular plication to treat acetabular dysplasia in artistic athletes.The orthopaedic journal of sports medicine, vol.(xx), pages 1 - 10 (japan).The study emphasizes on the investigation of the clinical outcomes and return to artistic activities after esa combined with labral repair and capsular plication for the treatment of acetabular dysplasia in artistic athletes.The patients evaluated on course of this study: 23 patients.The article describes the following procedure: labral repair performed using bioabsorbable suture anchors (gryphon br or competitor), esa performed with competitor ablator, bone graft secured using competitor bone tamp.The devices involved were: gryphon br absorbable suture anchors.Complications described: 3 patients were unable to return to artistic activities due to postoperative deep gluteal syndrome (dgs).All three treated with pt and steroid injections.One patient eventually received a surgical decompression of the sciatic and posterior femoral cutaneous nerve in the deep gluteal space.

• Brand Name: UNK - IMPLANT
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13549392
• MDR Text Key: 285747899
• Report Number: 1221934-2022-00497
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention