MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM TI LCP(TM) DISTAL RADIUS PLATE-STRAIGHT/LONG; PLATE, FIXATION, BONE

Catalog Number 442.490S

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 01/16/2024

Event Type  malfunction  

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: d2b: additional device product codes: hwc.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.

Event Description

Device report from synthes reports an event in japan as follows: it was reported that the patient underwent an open reduction/internal fixation surgery for a distal ulna fracture with the distal radius plate and locking screws on (b)(6) 2024.After the surgeon fixed the plate with three cortex screws, he inserted locking screws at the distal and proximal ends, but the locking screws penetrated the screw holes in the plate.The sales representative also confirmed that the locking screw penetrated through the screw hole without getting caught.The surgeon determined that fixation could not be achieved in this condition, so the distal radius plate was removed, and the wound was switched to a fixation with a k-wire and closed.The surgery was extended by 30 minutes due to the event, and the patient status/outcome was reported to be stable.This report involves one 2.4mm ti lcp(tm) distal radius plate-straight/long.This is report 3 of 3 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.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection found the threads stripped, this issue can be related to the reported allegation of unable to assemble.It is important to mention that insertion of the screw through the plate should be performed according to established procedure, overtightening can lead to an incorrect interaction of the devices.Surgical technique mentions for inserting locking screw: insert the locking screw manually with the self-retaining stardrive screwdriver.Carefully tighten the locking screw, as excessive force is not necessary to produce effective screw locking.A dimensional inspection for the device was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the lcp dorsal dist-radius pl2.4 straig 6ho would contribute to the complained device issue.Based on the investigation findings, and 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 reported complaint condition.As part of depuy synthes 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.

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.H3, h4, h6: photo investigation summary the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report however, a video was provided for review.The video investigation revealed that the locking screw can easily pass through some of the holes of the lcp dorsal dist-radius pl2.4 straig 6ho.It is not possible by evidence provided to assure if plate or screw are defective.However, it is important to mention that insertion of the screw through the plate should be performed according to established procedure, overtightening can lead to an incorrect interaction of the devices.Insert the locking screw manually with the self-retaining stardrive screwdriver.Carefully tighten the locking screw, as excessive force is not necessary to produce effective screw locking.The overall complaint was confirmed as the observed condition of the lcp dorsal dist-radius pl2.4 straig 6ho would 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 synthes 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 history part:442.490s, lot:5l14277, manufacturing site: werk grenchen, supplier:na, release to warehouse date: 25 jun 2019, expiration date:na.A manufacturing record evaluation was performed for the finished article lot 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 LCP(TM) DISTAL RADIUS PLATE-STRAIGHT/LONG
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18608802
• MDR Text Key: 334115074
• Report Number: 8030965-2024-01629
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982222879
• UDI-Public: (01)10886982222879
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091644
• 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: 442.490S
• Device Lot Number: 5L14277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/27/2024; 04/12/2024
• Supplement Dates FDA Received: 03/15/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR ø2.4 SELF-TAP L14 TAN; LOCKSCR ø2.4 SELF-TAP L14 TAN