MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; BONENAIL GUIDEWIRE

Catalog Number UNK - IMPLANT

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

Patient Problem Unspecified Infection (1930)

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.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).Since there was not contact information, no follow up attempts could be performed.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: zhao, l., et al (2020) outcomes of endobutton and rigifix femoral fixation methods with hamstring autograft in anterior cruciate ligament reconstruction.Chinese journal of tissue engineering research, vol.(24), pages 359 ¿ 365 (china).The study emphasizes on the analysis of the outcomes of two different femoral fixation methods (endobutton and rigidfix) with hamstring autograft in anterior cruciate ligament reconstruction.The patients evaluated on course of this study: 270 patients.The article describes the following procedure: anterior cruciate ligament reconstruction.The devices involved were: rigidfix biocryl femoral 3.3 mm st cross pin for femoral fixation of autologous hamstring.Complications described: post-operative complications for rigidfix group (occurrence timeline not provided by article): qty 1 infection.Intervention: "cleaning up".Qty 1 postoperative knee joint dysfunction.No further details provided and article does not report intervention.Qty 6 graft loosening.Article does not report intervention.

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.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).Since there was not contact information, no follow up attempts could be performed.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: zhao, l., et al (2020) outcomes of endobutton and rigifix femoral fixation methods with hamstring autograft in anterior cruciate ligament reconstruction.Chinese journal of tissue engineering research, vol.(24), pages 359 ¿ 365 (china).The study emphasizes on the analysis of the outcomes of two different femoral fixation methods (endobutton and rigidfix) with hamstring autograft in anterior cruciate ligament reconstruction.The patients evaluated on course of this study: 270 patients.The article describes the following procedure: anterior cruciate ligament reconstruction.The devices involved were: rigidfix biocryl femoral 3.3 mm st cross pin for femoral fixation of autologous hamstring.Complications described: post-operative complications for rigidfix group (occurrence timeline not provided by article): qty 1 infection.Intervention: "cleaning up".Qty 1 postoperative knee joint dysfunction.No further details provided and article does not report intervention.Qty 6 graft loosening.Article does not report intervention.

• Brand Name: UNK - IMPLANT
• Type of Device: BONENAIL GUIDEWIRE
• 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: 13578022
• MDR Text Key: 285946051
• Report Number: 1221934-2022-00571
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 02/22/2022
• 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