MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM; PLATE, BONE

Catalog Number 04.503.228.01S

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 09/13/2023

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.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: jey.D9: complainant part is not expected to be returned for manufacturer review/investigation.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 an unknown surgery was performed for the humerus on (b)(6) 2023.During the surgery, the 8mm screw¿s head broke when it was tightened while fixing the plate.The heads of two additional screws, 6mm to 4mm, also broke off.The shafts remained in the patient¿s body.There is a possibility that the front and back of the plate were inserted incorrectly.The surgery was completed successfully with no delay.There was no patient consequence; the patient outcome was reported to be stable.It was confirmed that there was no allegation against the plate.This report involves one ti matrixmidface screw self-drilling 8mm.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: a manufacturing record evaluation was performed for the finished device.Product code: 04.503.228.01s; lot: 43p6658.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: february 26, 2020; manufacturing site: jabil bettlach; expiry date: february 01, 2030.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: TI MATRIXMIDFACE SCREW SELF-DRILLING 8MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17876383
• MDR Text Key: 324984268
• Report Number: 8030965-2023-12598
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587019208
• UDI-Public: (01)10887587019208
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083388
• 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

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.228.01S
• Device Lot Number: 43P6658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MATMIDF L-PL 2+3HO R T0.5 TI.; MATMIDF ORBIT-RIMPL 12HO T0.5 TI.; SCR ø1.5 SELF-DRILL L6 TAN 1U I/CLIP.; UNK - GRASPING/HOLDING INSTRUMENTS.; UNK - HANDLES: CMF.; UNK - SCREWS: CMF.
• Patient Age: 76 YR
• Patient Sex: Male