MAUDE Adverse Event Report: SYNTHES GMBH LOCK SCR 2 SELF-TAP L5 TAN 1U I/CLIP; PLATE, BONE

Catalog Number 04.503.605.01S

Device Problem Difficult to Advance (2920)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Device not available - discarded.Initial reporter is j&j company representative.Device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested and is currently pending completion.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 (b)(6) as follows: it was reported that this was an ssro in the mandible on (b)(6) 2021.When the surgeon inserted the screw to fixate the plate (unk), the screw secured the plate less tightly than usual, a replacing screw was tightened to the plate.The procedure was completed without surgical delay as there was no harm to the patient.No further information is available.This report is for one (1) lock scr ø2 self-tap l5 tan 1u i/clip.This report is 1 of 1 for (b)(4).

• Brand Name: LOCK SCR 2 SELF-TAP L5 TAN 1U I/CLIP
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 12093635
• MDR Text Key: 259665131
• Report Number: 8030965-2021-05456
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819939691
• UDI-Public: (01)07611819939691
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.605.01S
• Device Lot Number: 68P3237
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1