MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP VOLAR RIM DIST-RAD-PL2.4 LE SHAFT; ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE

Catalog Number 04.115.751S

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/30/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Procode: hwc.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.

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 the open reduction internal fixation for the fracture of the distal radius.During the surgery, there was a possibility that the locking screw was protruding into the joint, so that the surgeon tried to remove the screw; however, the screw got stripped and could not be removed.The surgeon tried the following in an attempt to remove the screw.The surgeon put a screwdriver between gloves to increase friction.Additionally, the surgeon inserted the screwdriver into the screw head and turned the screw while pulling the screwdriver.Secondary, the surgeon put a chisel in the screw head threads and turned the screwdriver.Third, the surgeon the screwdriver while pressing the screw tip from within the joint.The surgeon tried the aforementioned things for approximately 45 minutes and put the chisel into the screw threads again and turned the screwdriver.As a result, the surgeon was able to remove the screw.The surgery was completed successfully with 45 minutes delay.According to the surgeon, the bone quality was very poor, and the screw head and the screw hole of the plate got stripped because the surgeon shook the screw.This report is for one (1) va lockscr ø2.4 self-tap l18 tan.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h3, h4, h6: part 04.115.751s, lot 483p202: manufacturing site: mezzovico.Release to warehouse date: november 24, 2021.Expiration date: november 01, 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.

Event Description

This report is for a va-lcp distal radius plate.

• Brand Name: VA-LCP VOLAR RIM DIST-RAD-PL2.4 LE SHAFT
• Type of Device: ORTHOPAEDIC FIXATION PLATE, NON-BIOABSORBABLE, STERILE
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14225302
• MDR Text Key: 290271172
• Report Number: 8030965-2022-02759
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819461451
• UDI-Public: (01)07611819461451
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.115.751S
• Device Lot Number: 483P202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: VA LOCKSCR Ø2.4 SELF-TAP L18 TAN.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 55 KG