MAUDE Adverse Event Report: SYNTHES GMBH PHN MULTILOC Ø9.5 IZQ CAN L160 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.016.039S

Device Problems Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2022

Event Type  malfunction  

• Brand Name: PHN MULTILOC Ø9.5 IZQ CAN L160 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13653743
• Report Number: 8030965-2022-01293
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign

Reporter Occupation

• Type of Report: Initial,Followup

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.016.039S
• Device Lot Number: 93P0626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown