MAUDE Adverse Event Report: SYNTHES GMBH VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO; PLATE, FIXATION, BONE

Catalog Number 04.111.630

Device Problem Device-Device Incompatibility (2919)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in malaysia as follows: it was reported on (b)(6) 2023, that surgeon used va drill sleeve to drill within the angle before inserting the first screw.However, the first screw couldn¿t lock to the specific plate hole.He then removed the screw and reinserted a new screw as he suspected it could be due to the damaged screw head.However, the second screw couldn¿t lock as well which led to the assumption of product defect by surgeon.Patient has osteopenia condition which is risky to reinsert the third time into the same hole.Hence, he decided to remove and insert the screw into another hole.We couldn¿t see the specific plate hole when surgeon complained as it has implanted into patient and unable to identify from the image intensifier x-ray images.Hence, lot/serial number of the plate and screw couldn¿t be identified as well.No adverse events resulted from the incident.It was just mentioned by the surgeon that patient has osteopenia, so he wanted to insert more screws to make the fixation stronger and more stable.Ultimately, that hole was left empty without any screws after failing multiple times.This report is for one (1) va-lcp-2-column drp2.4 volar r shaft 3ho 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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.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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Additional concomitant device added.Date of concomitant therapy is (b)(6) 2023.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.The product was not returned to depuy synthese, however photos were provided for review.The x-ray investigation found nothing indicative of a device issue or anything that would have contributed with the reported allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was unconfirmed.As the observed condition of the va-lcp-2-column drp2.4 volar r shaft 3ho would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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

It was further reported that the surgeon did not re-insert the same screw, but used a new, unused screw which also failed to lock to the plate hole.The screws used by the surgeon were screws intended to be used with the plate.The surgeon also clarified that by "couldn't lock," they meant that the screw would spin inside the hole.

• Brand Name: VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18130138
• MDR Text Key: 328032142
• Report Number: 8030965-2023-14274
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819352605
• UDI-Public: (01)07611819352605
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K083694
• 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,Followup

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 Catalogue Number: 04.111.630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Age: 67 YR
• Patient Sex: Female