MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM; SCREW, FIXATION, BONE

Model Number 04.211.032

Device Problems Device-Device Incompatibility (2919); Scratched Material (3020)

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

Event Date 01/19/2023

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.Procode: hrs.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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 japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent the spectroscopic fracture surgery for distal commissural fracture of the humerus with the products in question.Screw insertion was performed after drilling with a funnel-shaped sleeve in a va 2.7 hole, but did not lock.That screw in question was removed and another hole was used to fix the plate in question.The surgery was completed successfully without any surgical delay.The screw that removed had scratches on it.Inserting the removed screw into the plate sample locked it without any problem.It is inferred that the locking mechanism of the hole failed due to the gripping when the funnel-shaped sleeve was installed.This report is for a 2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 32mm.This is report 2 of 2 for (b)(4).

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 32MM
• Type of Device: SCREW, 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: 16361997
• MDR Text Key: 309377551
• Report Number: 8030965-2023-01710
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982119087
• UDI-Public: (01)10886982119087
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100776
• 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: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.211.032
• Device Catalogue Number: 04.211.032S
• Device Lot Number: 9L00545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: SLEEVE.; VA-LCP DHP 2.7/3.5 MED LE MED 2HO L82 TA.