MAUDE Adverse Event Report: AAP IMPLANTATE AG LOQTEQ® SCREW GUIDE SLEEVE 4.5, BLUE

Model Number IU 8210-45

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This is a late report due to a capa correction.

Event Description

In the course of returning an instrument set from the hospital, a missing color marking was discovered on one instrument.The discovery was made during aap's incoming inspection.

• Brand Name: LOQTEQ® SCREW GUIDE SLEEVE 4.5, BLUE
• Type of Device: GUIDE SLEEVE
• Manufacturer (Section D): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• Manufacturer (Section G): AAP IMPLANTATE AG; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• Manufacturer Contact: thomas batsch ; lorenzweg 5; berlin, berlin 12099 ; GM 12099
• MDR Report Key: 15655518
• MDR Text Key: 302432382
• Report Number: 3001406084-2021-00004
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/31/2021

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
• Device Operator: Health Professional
• Device Model Number: IU 8210-45
• Device Catalogue Number: IU 8210-45
• Device Lot Number: I005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1