MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER; PLATE, FIXATION, BONE

Catalog Number 04.111.531S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent an unknown surgery with the va-lcp two-column volar distal radius plate for the fracture of the distal radius.The surgeon drilled proximally the second hole of the plate from the distal radius side with the sleeve.When the surgeon inserted the va locking screw, it was not locked.The surgeon failed to remove the screw.The surgery was completed without removing the screw.No further information is available.This report is for one (1) 2.4mm ti va-lcp 2-col dstl rad pl nrw 6h hd/3h shaft/lt-ster.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: initial reporter is synthes sales representative product was not returned.Based on the information available, it has been determined that no corrective and 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.Device history lot: part # 04.111.531s.Lot # 440p201.Manufacturing site: (b)(4).Release to warehouse date: 05 nov 2021.Expiration date: 01 oct.2031.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/3H SHAFT/LT-STER
• Type of Device: PLATE, FIXATION, BONE
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13653557
• MDR Text Key: 289288154
• Report Number: 8030965-2022-01291
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819392250
• UDI-Public: (01)07611819392250
• 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,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: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.111.531S
• Device Lot Number: 440P201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - INSERTION INSTRUMENTS: TRAUMA; UNK - SCREWS: VA LOCKING
• Patient Age: 16 YR
• Patient Sex: Male