MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/8MM BAR; BONE PLATE

Catalog Number 04.511.422S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j 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 history lot, sterile part.Part: 04.511.422s, lot: 7l17843.Manufacturing site: (b)(4).Release to warehouse date: 18.Aug.2020.Expiry date: 01.Aug.2030.Unsterile part was manufactured at (b)(4).Product code: 04.511.422.Lot number: 52p1865.Manufacturing site: (b)(4).Release to warehouse date: 13 may 2020.A manufacturing record evaluation was performed for the not sterile 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2021 during a procedure, one (1) ti matrix sagittal split plate, one (1) 2.0mm straight plate, and two (2) 1.85mm ti matrix screws were unable to assemble.It was reported that the 1.85mm screw head felt too small for the plate.The procedure was successfully completed.There was a surgical delay of ten (10) minutes.There is no further information available.This report is for one (1) ti matrix sagittal split plate straight/4 holes/8mm bar.This is report 1 of 4 for (b)(4).

• Brand Name: TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/8MM BAR
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11921617
• MDR Text Key: 254632524
• Report Number: 8030965-2021-04475
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819360884
• UDI-Public: (01)07611819360884
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083388
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2021

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: 04.511.422S
• Device Lot Number: 7L17843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1