MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/3H SHAFT/RT-STER; PLATE, FIXATION, BONE

Catalog Number 04.111.630S

Device Problems Device-Device Incompatibility (2919); Difficult to Advance (2920)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an open reduction/internal fixation surgery for a distal radius fracture.After confirming the size, the surgeon set a drill guide in the most proximal hole of the tcp small 3-hole and used it as a handle to set the plate on the bone.At that time, the plate was repelled by the patient¿s soft parts, flew off, and fell on the ground.Only the plate became unusable because the drill guide was being held by the surgeon.After confirming the size again, the surgeon selected a standard 3-hole plate and completed the surgery without troubles.There was no surgical delay.The surgeon commented several times that he/she had difficulty getting the drill guide to stand straight when placing it on the plate.The surgeon also commented that he/she had tried both of 2 drill guides and neither one stood up straight.This report involves one 2.4mm ti va-lcp 2-clmn vlr dst rad pl 6h hd/3h shaft/rt-ster.This is report 1 of 1 for (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.H10: additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: initial reporter facility name: (b)(6) hospital.E3: reporter is a j&j employee.H3, h6: 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.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 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.H3, h4, h6 investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the va-lcp-2-column drp2.4 volar r shaft 3ho.According to the events mentioned on the description of the complaint " the plate was repelled by the patient's soft parts, flew off, and fell on the ground", surgical technique guide variable angle lcp two-column volar distal radius plate was reviewed and relevant statements were found: -note: for dense bone, visually inspect if the screw is countersunk after tightening with the torque limiter.If required, carefully tighten without the torque limiter until the screw head is flush with the plate surface.Properly handling and attention to the approved use of the device diminishes the risk of surgical delay.A dimensional inspection was performed for the va-lcp-2-column drp2.4 volar r shaft 3ho and met specifications.A functional test could not be performed as the mating device was not returned.The overall complaint was not confirmed as the va-lcp-2-column drp2.4 volar r shaft 3ho was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Dimensional inspection: feature: proximal hole diameter.Result: conforming.Device history part number: 04.111.630s, lot number: 7252p73, manufacturing site: mezzovico, release to warehouse date: 23 aug 2023, expiration date: 01 aug 2033.A manufacturing record evaluation was performed for the sterile finished 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.

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.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/3H SHAFT/RT-STER
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MEZZOVICO; via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18507734
• MDR Text Key: 333328507
• Report Number: 8030965-2024-00834
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819354371
• UDI-Public: (01)07611819354371
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,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: 04.111.630S
• Device Lot Number: 7252P73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/30/2024; 03/19/2024
• Supplement Dates FDA Received: 02/09/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: GUIDE