MAUDE Adverse Event Report: SYNTHES GMBH VA LOCKSCR ø3.5 SELF-TAP L65 SST; PLATE, FIXATION, BONE

Catalog Number 02.127.165S

Device Problem Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2023

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 the orif with the plate and the screw for the distal femoral fracture.Although the screw in question was inserted into the anterior most distal hole on the plate, it could not be locked.It was found that the screw penetrated the plate in question.Manual drilling was performed almost perpendicular to the plate.The surgeon decided to give up on removing it.The surgeon performed minimally invasive operation as much as possible, and when the plate was installed, the surgeon mistakenly drilled into the small hole instead of drilling into the large hole and crushed the hole.The surgery was completed successfully without any surgical delay.Patient's outcome/ consequences: stable no further information is available.This report is for one (1) va lockscr ã¸3.5 self-tap l65 sst.This is report 2 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.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 product code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.H4, h6 a manufacturing record evaluation was performed for the finished device product code#:02.127.165s.Lot #:5912p29.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 06/06/2023.Manufacturing site:jabil grenchen.Expiry date:01/06/2033.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: VA LOCKSCR ø3.5 SELF-TAP L65 SST
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL GRENCHEN; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18193618
• MDR Text Key: 328982663
• Report Number: 8030965-2023-14729
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07611819491014
• UDI-Public: (01)07611819491014
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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: 02.127.165S
• Device Lot Number: 5912P29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKING ATTACHMENT WASHER F/RETROGR FEM; UNK - PLATES: TRAUMA
• Patient Age: 89 YR
• Patient Sex: Female