MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG BIMOBILE; PRESS, PRODUCT

Model Number 184-360/00

Device Problems Fracture (1260); Material Fragmentation (1261)

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

Event Date 06/08/2023

Event Type  malfunction  

Event Description

Pin guide of press broke.

Manufacturer Narrative

The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.

Event Description

Pin guide of press broke.

• Brand Name: BIMOBILE
• Type of Device: PRESS, PRODUCT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 17324043
• MDR Text Key: 319105547
• Report Number: 3004371426-2023-00057
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 04026575185948
• UDI-Public: 04026575185948
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K190535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 184-360/00
• Device Catalogue Number: 184-360/00
• Device Lot Number: C210127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1